August's Top 5 Stories in Managed Care Pharmacy
Ethan Heidorn, PharmD
Senior Research Director, Market Access Consulting at Formulary Insights
Medicare Insolvency
Medicare: Insolvency Projections, 2026
Article Summary:
What: Each year the Medicare board of trustees submit an all-encompassing annual report on the program to Congress. The 2019 report projects an insolvency date of 2026 for the Medicare Hospital Insurance trust fund.
Why: It seems every challenger for the presidency has healthcare reform as part of their platform. We obviously have extremes from status quo Biden to blow it up Bernie, either way it is important to be informed consumers of political rhetoric. This will not be a dissection of specific Medicare proposals, we will get enough of that over the next year plus. Having an understanding of the basics of Medicare insolvency will be important in understanding conversations or headlines around the prospect of Medicare ‘already going bankrupt’ or being accelerated with certain proposals. The finances of Medicare are intensely important to the care of roughly 60 million Americans and the country at large.
Opinions and Insights:
Why don’t we Greg Louganis our way into this mess with a surface dive through the Medicare funds. Medicare has two separate trust funds, the Hospital Insurance Trust Fund (HI) and the Supplementary Medical Insurance Trust Fund (SMI). The Part A program, which is financed mainly through payroll taxes levied on current workers and income from the taxation of Social Security benefits, is accounted for through the HI Trust Fund. The Part B and Part D programs, which are funded primarily through general revenue and beneficiary premiums, are accounted for through the SMI Trust Fund. Increasingly, we also have bundled MA plans through private health plans for which payment is made on beneficiaries’ behalf in appropriate parts from the HI and SMI Trust Funds. (We’ve talked before about the GOT-level popularity of MA plans over solo PDP plans going forward). Medicare expenditures are driven by a variety of factors, including the level of enrollment, the complexity of medical services provided, health care inflation, and life expectancy. In 2018, Medicare provided benefits to about 60 million persons at an estimated total cost of $741 billion. This level of spend combined with projections for any expanded services has led to heightened concerns over the viability of the fund.
To better understand these concerns we’ll cannon ball into a contextual definition of insolvency. Insolvency refers to the point at which Medicare expenses are expected to exceed the generated funds of the trust. Medicare (the HI fund) does not become bankrupt in 2026, rather that is the anticipated year the program will finally run in the red. I must emphasize this, insolvency is not bankruptcy, and announcing it certainly will not make it go away. “Insolvency is a state of economic distress, whereas bankruptcy is a court order that decides how an insolvent debtor will deal with unpaid obligations.”
As mentioned, the funds for the HI trust come primarily from payroll taxes (currently 2.9% with no cap, and an additional 0.9% on earners of 200k + as part of the ACA). Funds from payroll taxes are subject to the health of the economy, population distribution, and rates, among various other factors. Even in 2026, when the HI trust fund is projected to be depleted, incoming payroll taxes and other revenue will still be sufficient to pay 89 percent of the HI fund. “The share of costs covered by dedicated revenues will decline slowly to 78 percent in 2043 (thanks boomers) and then rise gradually to 83 percent by 2093. This shortfall will need to be closed through raising revenues, slowing the growth in costs, or most likely both.” The HI fund will not run out of all financial resources and cease to operate after 2026, as the “bankruptcy” term may suggest in general political jargon.
Since the inception of Medicare in 1966, the HI Trust Fund has always faced a projected shortfall. The insolvency date has been postponed a number of times, primarily due to legislative changes that have had the effect of restraining growth in program spending. Various mechanisms have included: adjusting the payroll tax (most recently with the ‘wealth tax’ from the ACA), adjusting reimbursement rates commonly as part of budget reconciliation efforts (most notably in 1997 when we tried to balance the entire federal budget….hahaha no deficit, imagine that!), revamped efforts to detect FWA, and a little bit of fund dispersal. The projected insolvency dates displayed below are meant to highlight the sustainability of the program in the face of imminent danger over the years and tie much of the cost-containment success to legislative decisions, similar to how the current administration is pursuing efforts.
Due to the nature of its financing, the SMI Trust Fund (Part B and D) cannot become insolvent; however, the Medicare trustees continue to express concerns about the rapid growth in SMI costs. Premiums for Part B and Part D are set each year at levels that cover about 25 percent of costs; general revenues pay the remaining 75 percent of costs. "The trustees’ report does not project that these parts of Medicare will become insolvent at any point — because they can’t. The SMI trust fund always has sufficient financing to cover Part B and Part D costs, because the beneficiary premiums and general revenue contributions are specifically set at levels to assure this is the case." Any program pulling from the general fund always requires justification and novel attempts in containing costs. Future legislation will certainly look to curtail rising costs and achieve sustainability in both funds.
C’mon give me your 2.5 cents on Medicare-For-All:
In the event of expanding Medicare, the HI fund could raise capital through increasing employers' payroll-based taxes as the burden of providing healthcare would be relieved from their books. Although that number likely does not get close to covering the additional cost, it is a measure by which the government could reduce the forecasted deficit incurred from expanding coverage. Hospitals have been functioning (expanding, hiring, etc) under the assumption of commercial insurance payments (133% vs 77% for Medicare), a swift change in the payment structure is fundamentally disruptive to the current run of business. “The financial projections shown for the Medicare program in the report reflect substantial, but very uncertain, cost savings deriving from provisions of the ACA and MACRA that lower increases in Medicare payment rates to most categories of health care providers. Without fundamental change in the current delivery system, these adjustments would probably not be viable indefinitely.” The sentiment expressed in the conclusion of the report lends the idea that further reducing provider/hospital payments will function to significantly disrupt our ability to provide care in the acute setting.
There is no way around the fact we pay more for worse outcomes. This is also a loaded statement which minimizes the impact of: lifestyle and food culture (obesity), relative access, the wage gap, laws, subsidizing the rest of the world with innovation, etc. The CBO has an awesome review on the implementation and outlook of establishing a single-payer healthcare system in the US. I will leave out all comments on quality of care, access, innovation, reimbursement of providers, overall cost of care, role of insurers, FWA, implementation, viability etc etc.
So what should we do? Ha, nice try. Do I think we will get to single payer? No. Do I think we could get to a public option with the wealthy and employees of large businesses receiving private insurance and everyone else on the public option? Sure, you could envision that world. But then again, what in the world would I know and more importantly, where in the world is Waldo???
(You really think I would include a picture without Waldo in it??? Look harder)
Medicare Insolvency Projections:
https://fas.org/sgp/crs/misc/RS20946.pdf
Bankruptcy of Medicare:
https://www.cbpp.org/research/health/medicare-is-not-bankrupt
CMS Gives CAR-T Therapies the Green Light
CMS Says It Will Cover CAR-T for Medicare Beneficiaries Nationwide
What: "Issuing its long-awaited national coverage determination (NCD), Medicare will begin covering the growing collection of CAR T-cell therapies for cancer patients being treated in some REMS-enrolled healthcare facilities, CMS announced. In addition, Medicare will cover the FDA-approved therapies for off-label uses that are recommended by CMS'-approved compendia."
Why: We just looked at the insolvency of Medicare so why not discuss a spend driver that *might* get us closer! CAR-T coverage will fall under the SMI fund (Part B/D) where we will not worry about accelerating insolvency but rather premiums and general revenue contributions. CMS has kicked the can down the road on their coverage determinations for CAR-T therapies during the past year and a half before giving us their first initial guidance. The recommendations for coverage including access, monitoring, and reimbursement are crucial to understand for those qualifying Medicare beneficiaries. The NCD will likely be fluid in this situation.
Opinions and insights:
Buckle up, put the top down, we're taking this T-bird through the winding road CMS is pedaling down on their path to CAR-T coverage. CMS first initiated a national coverage analysis for CAR-T therapy for cancers in May 2018 and issued a memo in February proposing the decision to allow Medicare to pay for CAR-T. The decision was delayed several times until this month. In the initial discussion period, CMS had been seeking comment on the plans for coverage with evidence development (CED) including several data requirements. CMS wanted hospitals and clinicians to join a registry that tracks outcomes data for comparison with clinical trials. Clinical studies would be required to follow similar guidelines, including tracking data for two years after the treatment. The initial concern for approval was over a lack of high-quality data for which groups like the American Society for Transplantation and Cellular Therapy and AHIP had said making a NCD was "premature" citing concerns that it would create barriers to providing current and future CAR-T therapies.
However, CMS decided not to proceed with CED, which critics feared could overburden providers, causing some to opt out of offering CAR-T treatment to Medicare patients. “In its decision memo, CMS gave several reasons for removing the CED requirement. It noted that the FDA has required post-marketing studies of the therapy, which is used only in very specific cancer cases where there are no other options, and that this is an area of ongoing research. Routine costs of clinical trials of newer CAR T-cell therapies being studied is covered under their existing policy on trials. "CAR T-cell therapy has been shown to induce remission in carefully identified relapsed or refractory cancer patients in appropriate settings of care," said CMS. "Informed decision making between a physician and patient remains key to determining the best treatment."
Kymriah is priced at about $475,000 for a 1-time treatment and Yeskarta is priced at $373,000. “It’s estimated that the total cost of treatment can run between $800,000 and $1.5 million between drug cost, hospital administration fees, treatment of adverse effects (neurotoxicity, cytokine release syndrome etc.) and follow-up.” Early in the month, CMS finalized a payment decision for 2020 mainly aimed at increasing DSH payments and the hospital wage index issue, i.e. increasing rural hospital payments, which also increased the 'new technology add-on' payment from 50% to 65% for the next 2 years. This roughly translates into a “maximum add-on of $242,450, up from the current $186,500 payment”, delivering another win for the therapy. Although hospital administrators were looking for 100% reimbursement of the therapy. “Cancer centers have said that administering CAR-T costs at least $393,000 just for the customized cell-based treatment alone, and that does not include other costs, such as a possible stay in the ICU for severe complications.” CMS declined to give estimates of how much this would cost hospitals. We’ll be certain to follow the hospitals participating in CAR-T for how the final reimbursement numbers come to fruition.
“To reach its decision, CMS reviewed the evidence and also considered a report from ICER, which found the therapies are priced in alignment with their clinical value.” Distilling the ICER report down to the pulp shows an incremental cost-effectiveness ratio of approximately $46,000 per QALY gained for Kymriah as compared to clofarabine and $136,000 per QALY gained for Yescarta as compared to chemotherapy. The remission success for these therapies compared to the exhaustive efforts remaining is the driving force behind these numbers. (An incredibly tough ICER evaluation given the limited evidence)
How confident is CMS in this decision? I’d say they are about as clear as Justin and Hailey are on their wedding date. "I don't know that we've had an overall study to tell you this is going to be the cost to the overall Medicare program and when we are making coverage decisions, we are making that separate from how much this is going to cost the program," Verma said. "That being said, I do think the whole issue of CAR T is really bringing up the issue of how expensive the new therapies that are coming out. They're life-saving and they're transforming and we haven't seen this type of development before in terms of curative treatments. But I think it's sort of begging the question, 'How is the system going to pay for this over the long term?'" I agree, how are we going to pay for this? Shouldn’t you be able to have the framework for an answer to this seemingly rhetorical question by this point? With constricting budgets it will likely lead to decreased payments elsewhere, impacted premiums or heading to Congress seeking increased funding which is already staring down the barrel at Medicare cuts. (Doesn't mean this is wrong, we're supposed to pay for patients in the most dire of situations right?)
"At a time when the Medicare trustees have warned us that we're having problems paying for the Medicare program in six or seven years, this is something we're deeply concerned about," Verma said. "At the same time, we're committed to strengthening the program and want to make sure our beneficiaries have access to life-saving treatments. That's our first priority." It is very easy to empathize with the situation because the outcomes in remission rate for these patients having exhausted all other salvage therapies are incredibly encouraging even with the trial limitations. We are going to pay for this because of the incredible extension of life, but with constricting budgets we will likely make up this difference with decreasing spend in other treatment areas. CMS also said it is important to wait to collect cost data because the market will adjust. Love this. "A lot of times hospitals are able to negotiate with the manufacturers on the pricing. That's why it's premature for us to set a price or put anything out there because we also want to give time for the market to respond and to allow that negotiation to occur. So after some time, we can see what they've negotiated and we're better able to determine that pricing."
CMS seems to be unclear on the exact specifics required to implement these therapies on the reimbursement side, however, feels safe to say we can expect to see CAR-T come to Medicare with details percolating out along the way. This leads me to believe we will see this topic in the “story updates” section for months to come.
CMS Announcement:
https://www.ajmc.com/newsroom/cms-says-it-will-cover-car-t-for-medicare-beneficiaries-nationwide
ICER Report:
https://icer-review.org/wp-content/uploads/2017/07/ICER_CAR_T_Evidence_Report_021518.pdf
Amazon Battles SureScripts Over Data Access
Amazon threatens to sue major pharmacy player if it prevents PillPack from accessing patient drug data
What: “Amazon’s PillPack is considering legal action against Surescripts and other drug supply-chain players in a dispute over patient health data. That comprehensive data comes indirectly from Surescripts, which is owned by some of PillPack’s potential competitors, including CVS and Express Scripts.”
Why: “PillPack’s pharmacy delivery service relies on its access to an accurate list of its patients’ medications, so it can properly inform them about health and safety risks, uncover any duplicate prescriptions and help them keep up with refills. PillPack was informed this week that it will soon be cut off from patient medication data via a third-party entity, ReMy Health, a move that would seriously complicate its business.”
Opinions and Insights:
Plenty of intrigue and posturing. Nothing like a disruptor running square into established, stalwart dinosaurs. Aside from the general stranglehold on the supply chain, control over patient data may be the biggest advantage of the existing players over Amazon. This is the latest test of resilience and a bold move considering FTC finally brought monopolistic allegations against Surescripts this year (however trivial the lawsuit may be; call me crazy but regardless of specifics I’m never a blind fan of ~90% market share). As with many providers, PillPack goes through a third-party service, ReMy, which compiles the raw data from Surescripts and produces an interface for customer usability. The severing of this relationship severely hinders PillPack access to this data which will be impossible or costly to gain from traditional players directly threatened by their presence. Surescripts for their part contends that “PillPack does not have an agreement with Surescripts that in any way covers the use of this important PHI,” the statement said. Suresripts added that its portfolio does not include ‘any businesses where we are the source of medication history to retail pharmacies.’” PillPack, in response, noted that it has contracts in place to manage protected health information as a licensed pharmacy.
“Prescription history is only requested upon consent of the customer, and is held to the same data handling standards as all patient health information handled by PillPack,” Miller said. “Further, PillPack is a covered entity, the same as a physician’s office, and is bound by all healthcare privacy laws.” Such a fascinating game of cat and mouse; only one more interesting duo comes to mind…my money is on Amazon being Jerry in the end.
It’s all about the cheese: Jerry’s elaborate trap to 'keep that cheese' results in Tom being “Without access to Surescripts data, PillPack would lose the digital history on patients and would likely have to call each by phone to go through the list of their various medications and illnesses. That’s complicated as many of its patients consult with multiple doctors and are taking many medications that might be challenging to track. A PillPack spokesperson told CNBC that on average, its customers take seven medications per day.” PillPack for their part nobly postures that “by preventing patients from obtaining their own data or authorizing pharmacies to obtain their data, it makes health care more costly and in some cases dangerous when a pharmacy doesn’t have the complete patient history of medications." If I were legal counsel for either of these companies I know who I’d hire to protect the cheese; assuming one of my executives isn't named Prop Joe.
As I wrote this story, Surescripts "upped its battle with PillPack, accusing a third company [ReMy Health] of providing PillPack with patient prescription information 'fraudulently,' and turned the matter over to the FBI." Just when you thought we were approaching season 1 finale-level intrigue; we get flippin' FBI involvement! Seriously, can we just skip to season 5 after Marlo has fallen and be blessed with special arbitrator James Comey???!!? Fingers crossed.
CNBC Article on the Dispute:
MN Health Plans Compete on Capped Insulin Co-Pays
Medica introduces insulin cost relief program
What: “In Medica’s continuing efforts to address the rising cost of insulin, we are introducing a cap on the maximum amount commercial and individual market members will pay for their insulin. Starting January 1, 2020, all members of fully insured commercial groups headquartered in Minnesota and individual members in Minnesota will pay no more than $25 for each 30-day supply of insulin. This enhancement will apply to all insulin covered by their plan.”
“Beginning on January 1, 2020, Blue Cross will include Tier 1 and Tier 2* insulin options as a covered benefit with no member cost-sharing in plans where Blue Cross sets the health plan benefits and manages the financial risk. (fully insured) These include plans offered to Individuals and Families (both on and off MNsure); small employers; and most large employers.”
Why: Well, I live in Minnesota gosh darn it that’s why.
Opinions and Insights:
Last week Medica announced their insulin capping efforts for commercially insured members in 2020. The announcement was met with high praise from businesses, brokers, and press in the Twin Cities. Following said announcement, BCBS (MN) announced their $0 insulin cap program for their fully insured members in 2020. Although the parameters for said decision were likely in place as part of a contingency plan, it is hard to shed the copycat label for their move. That being said, there is nothing wrong with that; a $10 billion dollar industry is literally called the “Copy Cat” league...shout out Ronnie Brown.
Medica will switch their PBM services to Express Scripts beginning this year. The insulin capping program is actually an ESI product, branded as their “Patient Assurance ProgramSM” which they offer to clients. Still, Medica chose to opt-in to this program as a benefit to their members and engage in a fairly common relationship for PBM and health plan to allow the co-opting of programs. The symbiotic relationship essentially functions as a positive marketing tool for the PBM while allowing the health plan to receive the benefits (press, care, members) of the program. The implementation of these insulin caps comes as pressure mounts in the country and, in particular, Minnesota which recently experienced a highly-publicized death of a young man due to insulin rationing. As noted for ESI members the average spend of “$41.50 per 30 day supply” limits the new maximum co-pay to $25 (or $0) and most effectively targets those individuals in HDP’s which incur the disproportionately high costs early in the plan year. The 2020 paid premiums are reportedly not affected, as expected.
Due to legislation enacted in the 60’s, Minnesota had required health insurers doing business in the land of 10,000 lakes to be run as non-profits until 2 years ago when we finally allowed, among others, the healthcare giant in our own backyard to enter the market. The nature of the non-profit status combined with the heightened awareness culminated in this offering in the marketplace which was met with correspondingly enthusiastic praise (I happen to share a mediocre golf game with a broker in the state who can attest to the positive PR). Time will tell what the market may bear in the ongoing insulin accessibility battle and the evolution of such insulin capping on the insurer level (of course any self-insured employer could enact this strategy at any point). Medica and BCBS (UCare as well) delivered a much deserved win for many concerned individuals in the Minnesota market.
Local news: I touch on MN's health insurance market place in a previous article. I mention the $600 million reinsurance program our legislature enacted to keep premiums down for our residents. This spring the legislature battled over continuing the reinsurance program versus offering individual subsidies and the senate chose the reinsurance route which continues to allow our insurers to enact these programs without raising premiums (far more nuanced than that of course). Whether you believe those dollars are better spent as a ‘blank check’ to the insurers helping lower premiums versus applying the subsidies to individuals increasing affordability of premiums is another debate entirely (refer to my comments on income-based premium assistance manipulation for a hint).
Medica Press Release:
Blue Cross Blue Shield Press Release:
Ultomiris Launch More Successful Than Predicted and Amgen Holds off Sandoz, Celebrates with Otezla?
Alexion gets off to the races with key Ultomiris, Soliris launches
What: “Forty percent of Soliris patients treated for adult paroxysmal nocturnal hemoglobinuria (PNH) have switched over to the newer drug as of this week, a big jump from the 22% enrolled in April and the 3% Alexion execs quoted in early February.” “These numbers all suggest to us that in the U.S., in the PNH indication,” Alexion’s 70% conversion goal ‘should be achieved well before’ its year-end 2020 deadline, SVB Leerink analyst Geoffrey Porges wrote in a note to clients.”
Why: Soliris is one of the most expensive therapies in the world and semi-facing the patent cliff. Alexion increased the half-life to allow administration from q 2 weeks to q 8 weeks resulting in Ultomiris which has seen positive early conversion rates effectively extending their patent rights. Both have picked up indications in recent months contributing to their importance in rare-disease status.
Opinions and Insight:
The former heavy-weight champion of the world, Soliris, has given up its title in recent years to the Douglas-level underdog gene therapies, Luxturna, and most recently Zolgensma, carrying the Mayweather-esque controversy and all.
Tyson’s incredible reinvention and immersion back into public life and return to popularity through the Comedy Central Roasts and the Hangover movies has allowed him to work his way out of crippling debt; solidifying his legacy among a generation of fans. Alexion’s development of Ultomiris looked to hold down their legacy in PNH while simultaneously repurposing Soliris, gaining indications in atypical hemolytic uremic syndrome (aHUS) and NMOSD while moving along with the big launch in generalized myasthenia gravis (gMG), which “execs say things are going well on that front.” While the uber optimistic projection of $1 billion gain for Soliris with the NMOSD (ultra-rare autoimmune disease) indication is unlikely to be realized as therapy will be reserved for patients having failed the much cheaper Rituxin, it will remain a win for dominating salvage therapy.
Alexion has converted ~40% of the Soliris PNH patients to date with a mid-2020 goal of 70%, a fairly successful program. Priced at a 10% discount while also lowering hospital administration costs through lengthening the dosage interval (non-inferiority trials) may lend the more apt comparison to Tom Brady’s contract. Every damn year Brady takes a pay cut through extending his contract and prolonging the Patriots dynastic (Alexion's patent) run which ensures the Patriots remain prohibitive favorites each year. Not to burst the proverbial bubble, but the Jets, Bills, and Dolphins are no Buster Douglas; you can pencil in my best bet of the Pats at -450 for the AFC East this year.
The stock price has interestingly stayed stagnant at a slight decrease from 3 years ago. As mentioned, this ‘slight-product-improvement patent evergreening’ is posturing solid turnover to the patent protected Ultomiris, but the bleak pipeline is thought to be driving this stagnation. “In a note to investors, Porges said he was ‘quite cautious’ on Alexion’s upside as the drug maker faces a potential Soliris biosim from Amgen in Europe.” Interesting to note that Amgen is developing the biosimilar while at the same time surfacing rumors of their purchase of Alexion. Amgen has been under pressure “to do something to cushion the $2 billion in lost revenues it’s expected to suffer as key drugs like Neulasta and Sensipar fall to biosimilar competition.” Amgen is considering this purchase to deliver short-term revenue gains in the wake of the biosimilar competition coupled with their own interest in the disease state.
Naturally, news had to surface prior to publishing whereby the patent office is taking up Amgen’s suit against Alexion through the IPR pathway (as discussed in February’s stories) to challenge the Soliris patents in hopes of facilitating their biosimilar launch in ~2022 as opposed to 2027. It would appear this mulled purchase has been sidelined for a run with their own product. This decision falls in line with other developments for Amgen this month. The drug maker recently picked up an enormous, with a capital B, patent win for Enbrel to keep Novartis’ Sandoz biosimilar, Erlezi, off the market which may have emboldened their bidding in the Otezla sweepstakes. As part of the BMS buy-out, Celgene had to sell off their psoriasis blockbuster due to BMS' internal development of a competitor. Amgen more than jumped on this opportunity with the 13.4 billion dollar purchase “in spite of the 10 billion dollar estimated value.” With a mound of cash waiting to be spent, Amgen made their play into psoriasis (and further their inflammatory portfolio) with an immediate revenue generator that is expected to return positive investment in 7-10 years. They have been mysteriously quiet in the M&A game this year, with the CEO even facing criticism from some analysts; these moves look to quell some of the noise.
Ultomiris Switch-Over Success:
https://www.fiercepharma.com/marketing/alexion-gets-off-to-races-key-ultomiris-soliris-launches
Amgen Purchases Otezla:
https://seekingalpha.com/article/4289031-otezla-high-cost-strategically-aligned-acquisition-amgen
UNH Suing Generic Drug Cartel
"Thanks to groundwork laid by state AGs—who've been going after generics companies for alleged price fixing—UnitedHealthcare is suing dozens of copycat drugmakers for essentially the same thing. And the insurance giant is trying to claw back money it spent on allegedly overpriced drugs.
In a 355-page lawsuit, UnitedHealthcare sued the companies for collusion, naming a group of "core conspirators" that includes Teva and Mylan, as well as dozens of other drugmakers. UnitedHealthcare, the largest insurer in the U.S., aims to claw back financial losses it says it suffered because of the inflated prices." Humana as well.
FDA: Gene Therapy Maker Submitted Manipulated Data Before Drug Was Approved
In a statement, Novartis said it is “fully confident in the safety, quality and efficacy of Zolgensma.” The drugmaker said AveXis investigated allegations of data manipulation and “once we had interim conclusions from our investigations, we shared our findings with the FDA.” The data, the company added, “are limited to an older process no longer in use.”
The FDA approved the gene therapy on May 24. On June 28, Marks said, AveXis told the agency about the data problem, which involved tests comparing older and newer versions of the gene therapy. The FDA said the company began investigating the data problem in March.Marks said he was most concerned that the manufacturer “submitted data that was inaccurate to us as part of their application and that led us to approve a product potentially sooner than we might have."
Marks said he was most concerned that the manufacturer “submitted data that was inaccurate to us as part of their application and that led us to approve a product potentially sooner than we might have."
Catch Up on July's Top 5 Stories Here!
https://www.dhirubhai.net/pulse/catch-up-julys-top-5-stories-managed-care-pharmacy-ethan-heidorn/
Special Thanks
Special thanks to my mentors and other professionals that helped me gain a greater understanding of these stories.
Final Note
*All comments are opinion based and subject to fair criticism and disagreement or further enlightenment.
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