News Digest: 03 Jan 2024
Remap Consulting
Solving your pricing and market access challenges to improve patient access ??
We summarise the latest pricing and market access news in the pharmaceutical industry ??
2024’s VPAG details now published in full
The 2024 Voluntary Scheme for Branded Medicines Pricing, Access, and Growth (VPAG) has been unveiled as the successor to its predecessor, VPAS, effective January 1, 2024, for a 5-year duration. With a focus on improving patient outcomes, supporting economic growth, and ensuring a financially sustainable NHS, the detailed publication outlines key aspects:
The publication also unveils details about VPAG's affordability mechanism, with older medicines facing a 10% baseline payment rate and potential top-up payments. Technical guidance on product categorization and clarifications on reference pricing are also provided. Additionally, the full publication outlines clear timelines and commitments for reviewing the budget impact test threshold and the Commercial Framework's indication-specific pricing mechanisms, both launching within the scheme's initial 6 months.
Richard Torbett, Chief Executive of the ABPI, expressed satisfaction, noting that the VPAG allows sector growth and reduces rebate rates. He highlighted the commitment to enhancing the commercial environment and providing clarity on the scheme's operation.
Suppliers of branded medicines have until January 15, 2024, to decide participation in VPAG or default to the updated Statutory Scheme for 2024, which has faced recent industry criticism. For more information on the Statutory Scheme, click here.
The Federal Cabinet has announced the new pharmaceutical strategy in Germany
On December 14 the German Federal Cabinet approved its national Pharmaceutical Strategy. Many of the topics have been floated in other publications and speeches but they are brought together here.
The document consists of eight chapters which aim to strengthen and expand Germany as a location for innovation and production.
The eight chapters are as follows:
Perhaps the most interesting from a market access perspective is chapter seven which contains details of the AMNOG reform, allowance of confidential discounts (where it is specified that it must not lead to additional bureaucracy or expenditure for the health system) and the change in the fixed rebate from 12% to 7%.
领英推荐
France paves the way for faster access to ground-breaking treatments with direct access program for Hemgenix Gene Therapy
CSL Behring's Hemgenix, a breakthrough gene therapy for haemophilia B, recently achieved the distinction of being the first drug authorized under France's new "direct access" program. This initiative signals a notable departure from the traditional drug access path, streamlining the journey for highly innovative therapies and sidestepping prolonged and intricate price negotiations that often impede timely access.
Unlike the conventional route in France, characterized by intricate negotiations between pharmaceutical companies and bodies like the Economic Committee for Health Products (CEPS), the "direct access" program functions as a more efficient pathway. This streamlined process accelerates access for drugs recognized as highly innovative and offering significant medical benefits, as determined by the Haute Autorité de Santé (HAS), the French health authority. Specifically tailored for revolutionary advancements like gene therapies, where conventional negotiation comparisons may be less relevant due to a lack of comparable predecessors.
For those grappling with haemophilia B, a life of dependence on intravenous infusions is a challenging reality. Hemgenix presents a transformative solution, offering a one-time gene therapy that has the potential to liberate patients from this burdensome routine, significantly enhancing their quality of life and envisioning a future free from frequent hospital visits.
Dr. Lutz Bonacker, CSL Behring's European general manager, sees this development as a beacon of hope not only for French patients but for the entire continent. He anticipates it opening doors to similar "innovative access solutions" across Europe, potentially revolutionizing access to cutting-edge treatments for millions.
While France's program is a significant leap forward, some advocate for further progress. In contrast to Germany's system, which allows immediate drug launch upon approval, bypassing the initial appraisal step, France's program currently focuses on therapies with major medical benefits. Nevertheless, despite these potential areas for improvement, France's "direct access" program represents a crucial step toward a more equitable and efficient healthcare landscape.
Biden administration targets 48 drugs in crackdown on medication price hikes
In preparation for the 2026 Medicare drug-price negotiations, the Biden administration is taking a stand against pharmaceutical companies that have increased medication costs at rates exceeding inflation. As part of the 2022 Inflation Reduction Act (IRA), the White House plans to enforce rebates on 48 Medicare Part B drugs whose prices surged beyond the inflation rate in the final quarter of 2023. Notable medications flagged for rebates include Novartis' Kymriah, Seagen's Adcetris and Padcev, as well as Amgen's Prolia and Blincyto.
Starting January, Medicare patients using these drugs may experience reduced coinsurance payments. For medicines on the list, the federal government plans to invoice drugmakers as a penalty for the speedy price hikes and deposit the rebates into the Medicare Trust Fund. Then, the funds will go toward patients' coinsurance payments.
The administration's recent determination to reclaim patents of certain high-priced drugs further underscores its commitment to reducing drug prices, while the Federal Trade Commission takes additional measures to regulate drug prices outside the IRA framework.
We always welcome your thoughts and opinions on the topics raised here.
If you’d like to have a conversation on any of the insights in this newsletter, or explore how we can support you in getting your product to market, email us at [email protected] or pop a comment on this post!