Say it ain’t so! Don’t get diagnosed with multiple myeloma in England, Northern Ireland, Scotland or Wales. New austerity measures could result in an early death sentence for our brothers and sisters with myeloma in the UK. I wasn’t planning to write about this today, but I became so upset after reading an article on PharmaTimes.com last night, I felt I needed to alert our readers.
Yes, I had heard that the British were cutting back on approval of a number of cancer meds. But it seems to me that multiple myeloma patients are being hit especially hard. While I’m not surprised that panobinostat wasn’t approved (the marginal drug was barely approved by the FDA here in the States) I was shocked to learn that Revlimid was on the “we won’t pay for it” list; pomalidomide, too.
Read the short article:
NICE ‘no’ for Novartis’ Farydak a blow for multiple myeloma patients
Daily News | September 15, 2015
UK patients with myeloma have been dealt yet another blow after cost regulators issued a preliminary rejection for the use of Novartis’ Farydak by the National Health Service in England and Wales.
The National Institute for Health and Care Excellence is currently appraising the drug’s use in combination with Celgene’s Velcade (bortezomib) and dexamethasone to fight the condition in patients who have already received at least two prior therapies.
Farydak (panobinostat) is the first cancer medicine to target enzymes known as histone deacetylases, offering a novel mechanism of action different from other MM treatments on the market.
Clinical data underpinning the drug’s European approval earlier this month show that it can boost progression-free survival; patients receiving the Farydak regimen saw a delay in their disease progression of about 7.8 months more than those given Velcade/dexamethasone alone.
NICE said its independent review committee heard from the clinical and patient experts that the drug may provide an additional treatment option for patients because of its different mode of action when compared with existing treatments, but did not consider it a step-change in treatment.
Also, the Committee concluded that Farydak failed to meet the short life expectancy, extension to life criteria, and that it was not possible to determine the most plausible incremental cost effectiveness ratio for the drug, “because the appropriate analyses had not been presented”.
News of the preliminary rejection will be particularly concerning to patients given that recent cuts to England’s Cancer Drugs Fund included multiple myeloma treatments Celgene’s Revlimid (lenalidomide) and Imnovid (pomalidomide), leaving patients with no alternative options if they fail to respond to standard therapies.
Novartis said it is disappointed with the decision, but that it will continue to “work closely” with NICE to achieve a positive final outcome for patients.
“With nearly half of multiple myeloma patients currently not expected to survive past five years, this is a wholly unacceptable situation that is indicative of the wider issues surrounding the assessment of, and access to, cancer medicines in England,” the Swiss drug giant said in a statement.
Apparently patients do have access to thalidomide, but as my recent experience reminds us, using it can cause an unacceptable amount of often irreversible peripheral neuropathy (PN), especially when compared to the equally–sometimes more effective–Revlimid.
I understand Revlimid has been slow to catch on in most of Europe because of the cost. There I believe Revlimid is a drug of last resort. But come on, people; time to join the 21st Century!
Our medical system here in the States is inherently flawed. But for most multiple myeloma patients, our access to the latest anti-myeloma meds gives us a big leg up over the UK, Europe and even Canada.
I’m going to take this opportunity to remind our European brothers and sisters that most clinical trials in the U.S. are open to non-citizens. Yes, there’s the cost of travel and housing once you’re here. Its an opportunity to jump into one of the base combinations studies featuring Kyprolis and/or Pomalyst, or in the case of the UK, even RVD. (Rev/Velcade/dex).
We have quite a few international readers here at MMB. Not a lot from England. But if you need help gaining access to new meds, let me know and I’ll get our incredibly smart and helpful readers on it right away! Glad to help anyway I can.
Feel good and keep smiling! Pat