After a meeting this week, the Danish Medicines Council still refrains from recommending the drug Spinraza as standard treatment for the rare and incurable disease spinal muscular atrophy or SMA type 2.
This is according to a release from the Medicines Council.
“Due to existing data and the excessive price, we cannot recommend nusinersen (Spinraza, ed.) as possible standard treatment for all patients with 5q muscular atrophy. We urge studies to provide new data to prove the effect of nusinersen,” says Jørgen Schøler Kristensen, who led the council meeting and shares the chairmanship in the Medicines Council with Steen Werner Hansen.
“The applicant has provided a new price but no new data. The price is still too high compared to the documented effect and therefore, we maintain our decision,” adds Schøler Kristensen.
The applicant has provided a new price but no new data. The price is still too high compared to the documented effect and therefore, we maintain our decision
Despite the rejection, the Medicines Council considers Spinraza suitable for a small group of patients, including infants who do not have any symptoms of their disease yet.
Offered lower price
The Medicines Council refused Spinraza even though the manufacturer of the drug, the pharma group Biogen, offered the drug for a lower price than originally. In October last year, Spinraza was found too expensive and despite the discount, the council maintains that Biogen demands an “excessive” price and that the effect of the drug is not sufficiently documented.
But the Medicines Council is wrong on all points, according to Janne Harder, General Manager in Biogen Denmark, who does not understand the council’s decision.
“We consider it necessary to stress that the Medicines Council’s rejection referring to high prices is not factually based. We have offered a new and favorable price for Spinraza that was approved by the Swedish authorities for type 1 and 2 and some type 3 patients,” she says in an interview with MedWatch.
Harder refers to Sweden’s equivalent to the Danish Medicines Council, the New Therapies (NT) Council. Recently, the NT Council approved Spinraza for treatment of SMA type 1 and type 2 in patients under 18 after Biogen negotiated a “fully competitive price” that, according to Biogen, is on a par with the price the Danish Medicines Council just turned down.
“Thus, the Medicines Council’s refusal must be based on its own calculations of how much Denmark is willing to pay for such a drug,” says Harder.
Spinraza’s official list price (the pharmacies’ purchase price) is DKK 620,000 (about USD 103,490) per dose. The therapy consists of four starting doses to be taken at 14 days intervals. After that, the patient receives one dose every four months. In the first year of treatment, the patient then receives six doses and afterwards three doses each year. It amounts to a price of DKK 3.72 million (approximately USD 620,000) the first year and DKK 1.86 million (USD 310,000) in the following years.
However, the price Biogen presented for Amgros, the Danish regions’ pharmaceutical procurement service, is most likely lower. Harder does not want to reveal how much lower.
“As agreed with Amgros, we do not make our agreement prices public,” she says.
The General Manager does not agree that Biogen’s price is too high or unfair. Neither does she accept the Medicines Council’s grounds of lacking documentation for Spinraza’s.
We cannot give Denmark special treatment. The prices we offered the Medicines Council are already comparable with the biggest countries in Europe that approved Spinraza for much bigger SMA populations than the Danish
“Obviously, we do not agree with this explanation. Please note that the authorities in Sweden, Germany, Italy, France, Luxembourg, and Austria found the data sufficient for approving Spinraza for SMA therapy. Actually, the German Institute for Quality and Efficiency in Health Care, IQWIG, recently assessed treatment with Spinraza of “significant” value of for children with SMA type 2. This assessment differs greatly from the Danish Medicines Council’s,” she says.
She adds that Biogen continuously receives new data from studies with Spinraza and that the company analyzes the results to further strengthen evidence and effect of the drug:
“I promise, particularly the patients, that as soon as we receive new data, we will collect them and file another application for Spinraza with the Medicines Council. But I cannot guarantee that we are ready in three months when we, according to law, can apply again. I hope so but it depends on how fast we receive data.”
What is for sure is that Biogen will not reconsider the price for Spinraza for “a long while.”
“We cannot give Denmark special treatment. The prices we offered the Medicines Council are already comparable with the biggest countries in Europe that approved Spinraza for much bigger SMA populations than the Danish,” says Harder.
MedWatch would have liked to hear from one of the Medicines Council’s chairmen, Steen Werner Hansen or Jørgen Schøler Kristensen, but is has not been possible to get their comments.
English Edit: Ida Løjmand
Would you like to receive the latest news from MedWatch directly in your e-mail inbox? Sign up for our free English newsletter below.
Mere fra MedWatch
Det var et fejlskud at ansætte Catherine Mazzacco som adm. direktør for Leo Pharma, vurderer headhunter, der ser afgangen som et naturligt skridt forud for børsnoteringen af Leo Pharma. Til at styre den proces i mål vil bestyrelsen efter alt at dømme skulle til udlandet for at finde den rette profil, lyder det videre.