German HTA Rejects 'Major Added Benefit' Claim For Celgene's Imnovid
This article was originally published in Scrip
Germany's health technology appraisal body IQWiG, the committee responsible for evaluating new medicines prior to pricing negotiations in the country, has given Celgene's multiple myeloma therapy Imnovid (pomalidomide) a rating of "no added benefit" over other available treatments.
Celgene claimed a "major additional benefit" rating in its submission to IQWiG and at the time of the drug's initial approval German regulator, the Federal Joint Committee (G-BA), also said the product had a significant additional benefit. Celgene based its evaluation of the drug on positive data from the MM-003 registration trial. It has also since provided more data from this trial to the German HTA, which showed a reduced mortality risk by 47% and a gain in overall survival by 5 months in refractory multiple myeloma patients treated with Imnovid.
However, IQWiG has said in its assessment this month that the drug offers no additional benefit due to "methodological reasons."
Martin Völkl, director of market access and public affairs at Celgene GmbH, told Scrip this outcome is because, according to IQWiG, the dossier submitted by the company does not include appropriate data to deduce an additional benefit. He said, "The comparator determined by G-BA, an active therapy individualized on the respective patient, was not realized based on the methodological standards of IQWiG. Celgene, however, considers high-dose dexamethasone, the active comparator agreed on with US FDA and European Medicines Agency (EMA) for the registration trial MM-003, as an appropriate comparator and best standard of care."
The GB-A will provide a final decision on Imnovid's benefit rating, taking into account its HTA's recommendations, in March this year.
Celgene said that at this point it "will not speculate on the final outcome from the GB-A." However, the company noted it is "committed to working closely with all parties involved in the ongoing process and will provide all necessary pieces of information to underline why Celgene continues to claim a major additional benefit for Imnovid."
Next Steps
The company said that following the GB-A's final decision, subsequent price negotiations will start at which time it will "work collaboratively with all stakeholders involved in the process to identify the best approach and solution." This could include a special pricing arrangement in the country.
Celgene will also get the chance to argue its case for a better benefit rating in Germany at an oral hearing next month. The company will also submit a written position on the IQWiG assessment report to German regulators.
Current Use In Germany
Imnovid was approved by the EMA in August 2013 in combination with low-dose dexamethasone for the treatment of relapsed/refractory multiple myeloma in adult patients who have received at least two prior therapies including both lenalidomide and bortezomib and have demonstrated disease progression on the last therapy. IQWiG's current review was automatically initiated in line with German legal regulations for drug pricing because Imnovid's cost exceeded a pre-set revenue threshold.
Celgene noted that since the drug's introduction to the German market it has been prescribed to more than 2,500 patients. The company said that in the year 2016, the disease is expected to affect approximately 3,800 men and 3,000 women in Germany, underlining the "high need for additional therapy options in this area."
"Since its approval two years ago, pomalidomide has become a valuable pillar in the treatment landscape for patients with relapsed/refractory multiple myeloma,” said Professor Dr. Christian Straka, head of the department of hematology and oncology at the Schön Klinik Starnberger See and chair of the Project Group Multiple Myeloma at the Munich Tumor Center, in a statement.
Celgene added that shortly after market authorization, myeloma experts confirmed Imnovid's status as a standard of care treatment and the guidelines issued by the German Association for Hematology and Oncology (DGHO) were updated accordingly. "This underlines how important this treatment alternative is for patients with relapsed/refractory multiple myeloma in Germany," Völkl said.
Pricing Issues Elsewhere
Celgene has also had trouble securing a price for Imnovid elsewhere in Europe. In 2015 the UK's HTA body NICE (The National Institute for Health and Care Excellence) also return a negative verdict, deciding not to recommend the drug for use on the UK's National Health Service. The drug was reviewed in combination with dexamethasone as a third-line treatment after bortezomib and lenalidomide, but NICE found that it was not value for money. Also the committee was not convinced about the drug's benefits. It noted in February, in a final draft guidance for the product, that "there was substantial uncertainty about the relative effectiveness of pomalidomide compared with current care."
Unlike in the UK, Celgene highlighted that HTA benefit assessment in Germany is purely about additional benefit, so price does not play any role in IQWiG's response and in the G-BA decision.
The company noted that Imnovid has received positive HTA assessment and reimbursement decisions in France, Italy, Spain, Scotland and Wales in the UK, and in several other countries.