New endometriosis pill approved on NHS in England
Amit Vaidya
Executive Board Advisor & Consultant. International scaleup. Go-to-market options. Optimising international scaleup through distributors. Improving business development success in complex sales for B2B service providers.
At last! A pill for those women suffering endometriosis. This is a combination treament developed by a collaboration between Pfizer and Myovant Life Sciences back in 2020.
The collaboration first produced Relugolix for prostate cancer.
I sold Goserelin (Zoladex) in Prostate Cancer AND Endometriosis AND Fibroids. Relugolix and Zoladex are Gonadotrpin Releasing Hormone Receptor Antagonists (GnRH recepor antagonists). In prostate cancer, they block the production of testosterone (the tumour is testosterone-dependent for growth).
In effect, they are therapeutic alternaives to surgical castration.
Zoladex is a 1-month or a 3-month depot injection, whilst Relugolix is oral tablets.
Now lets shift to women and endometriosis.
Endometriosis tissue is hormonally-dependent follwing the normal the changes in hormone levels during a menstrual cycle.
By combining the Relugolix with female hormones they crete a combination therapy 40 mg relugolix, 1 mg estradiol, and 0·5 mg norethisterone acetate that
suppresses production of luteinising hormone and follicle-stimulating hormone?and ovarian oestradiol and progesterone production.
In women with endometriosis-associated pain, treatment with 40 mg relugolix monotherapy daily for 24 weeks was associated with significant reduction in pelvic pain compared with placebo, with efficacy similar to leuprolide.
However (and there is always a catch):
Dose-dependent decreases in bone mineral density and increases in vasomotor symptoms with the combination therapy mean that monotherapy relugolix is not suitable for long-term use.
Let me try to put this "wonder drug"into context. It is not new. In combination with oestradiol and norethisterone (both having been around donkeys years) it is new. But Zoladex is effective in endometriosis also as is Leuprolide -but they are both injections.
It is estimated around 1.5 million owmen suffer endometriosis in the UK.
The mainstay is hormonal manipulation through the use of the combination contraceptive pill is much cheaper to the NHS (unlike the Relugolix combination priced at ￡72 for 28 days).
Of those 1.5 million women, how many will qualify for treatment with this new combination pill?
Answer? Not many.
NICE has issued a statement:
"It will only be available on the NHS for people who have already tried all other medical and surgical treatments and found they did not help, NICE said - equivalent to 1,000 women a year".
In my past corporate life selling Zoladex in endometriosis, I recall that it took on average around EIGHT years for women to be diagnosd with the condition. Many were "fobbed off" by their GP as having "low pain threshold" and that they should "put up with 'period pains'.
Referral to a gynaecologist for a full pelvic examination is still frightfully slow.
So, on the one hand, good news with an oral combination therapy.
Bad news?
NICE has restricted use to an arrow sub-set of women who can be considered for treatment - and (my take) IF their local Integrated Care Boards (ICBs) set aside the local funding for the treatment.
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#endometriosis #nhs
Executive Board Advisor & Consultant. International scaleup. Go-to-market options. Optimising international scaleup through distributors. Improving business development success in complex sales for B2B service providers.
5 天前Given that NICE recommendation is to give access to less than 7% of sufferers, I wonder what the marketing team forecast for sales was and what % it was based on? 15% uptake? 20% ? 30% ? If it was more than 7% adoption, they will be disappointed for sure. Now if I were GM in England, I'd be asking them for their proposal of how they intend to make up the deficit between target and actual. My staff used to cringe when I'd ask them. There was no letting them off the hook. Those who made the forecast, own the forecast and have to answer how the shortfalls are going to be made up. Then I'd walk away......waiting for their response........