France's Transparency Commission of the Higher Authority on Healthcare has recommended breast cancer drug Kadcyla for reimbursement and adopted new recommendations further to the indication extension of the hepatitis drug Pegasys.
IHS Life Sciences perspective | |
Significance | The Transparency Commission of the Higher Authority on Healthcare has adopted two positive decisions on originator drugs for their reimbursement under the French healthcare system. |
Implications | The two treatments have been judged to bring important clinical value, providing patients with access to these treatments with reimbursement rates between 65–100%. |
Outlook | Roche has secured favourable pricing negotiation position for its breast cancer drug Kadcyla as the TC has maintained that the drug brings significant improvement in actual benefit, enabling the company to obtain the European-level price guarantee, whereby the price cannot be below the lowest of the same drug in the reference markets, namely Germany, Italy, Spain, and the United kingdom, for five years. |
Roche's breast cancer treatment Kadcyla secures ASMR II
French Transparency Commission (TC) of the Higher Authority on Healthcare (HAS) has issued a reimbursement recommendation for Roche's (Switzerland) oncology drug Kadcyla (trastuzumab emtansine) in 100 mg and 160 mg powder for infusion. Kadcyla is indicated as monotherapy of human epidermal growth factor receptor 2 (HER -2) positive metastatic breast cancer in patients who previously received trastuzumab and a taxane, separately or in combination. Patient should have either received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy. The TC also maintained that the clinical value rating (SMR) for Roche's treatment is "important" SMR. The commission has also indicated that clinically relevant comparators for Kadcyla in the treatment of HER2 positive metastatic breast cancer progressing after treatment with trastuzumab and taxane are the combination of GlaxoSmithKline's (GSK; UK) Tyverb (lapatinib) and Roche's Xeloda (capecitabine) as well as the combination of Tyverb and Roche's Herceptin (trastuzumab). In addition, the combination of Herceptin and Xeloda has been defined as a situation temporarily acceptable, subject to a temporary treatment protocol. Furthermore, the TC evaluated that Kadcyla brought an improvement as monotherapy versus the association of Tyverb and Xeloda in terms of progression-free survival and overall survival and an overall safety profile acceptable, the Commission considers that transparency Kadcyla monotherapy provides significant improvement in actual benefit (ASMR), and thus granted an ASMR II for the treatment of HER2 positive metastatic breast cancer. The full reimbursement decision is available, in French, here.
Indication extension granted to Roche's Pegasys
Furthermore, Roche has secure indication extension for Pegasys (peginterferon alfa-2a) for the treatment of hepatitis C children and adolescent patients aged five years or over. In addition, the drug has been also evaluated in its new 90 mcg dosage in all the indications. The commission has assessed that the clinical value rating (SMR) for Roche's Pegasys is "important" SMR for its new paediatric indication as well as for its 90 mcg dosage. The TC indicated as relevant comparator Schering-Plough (Subsidiary of Merck & Co, US) ViraferonPeg (peginterferon alfa-2b). In addition, according to the evaluation published by the TC, the drug does not bring any improvement in actual benefit (ASMR V) for the treatment of hepatitis C. The full reimbursement decision is available, in French, here.
Outlook and implications
The inclusion of Kadcyla in the reimbursement list represents encouraging news for Roche. In particular, the evaluation concerning the improvement in actual benefit places Roche in a favourable position for the pricing negotiations with the French pricing committee. The drug was approved for commercialisation in Europe by the European Commission in November 2013 (see Europe: 20 November 2013: Roche's Kadcyla granted approval in the EU).
The positive opinion on reimbursement for Kadcyla granted by the TC follows a positive trend observed in recent decisions adopted by national health technology assessment bodies. In particular, the breast cancer treatment has been approved for reimbursement in Japan further to a cost calculation assessment (see Japan: 15 April 2014: Latest NHI listings in Japan include SGLT2 inhibitor Suglat, cancer drugs Kadcyla, Adcetris, and Giotrif). Similarly, the German IQWiG has evaluated that Kadcyla brings major additional benefits, although final decision is expected to be published in three months (see Germany: 2 April 2014: Germany's IQWiG judges two new oncology drugs to show hint of major additional benefit). Conversely, NICE has published negative opinion in a draft guidance not recommending Kadcyla due to the fact that the incremental cost-effectiveness ratio is above the range for a drug to be considered cost-effective within the National Health Service (NHS; see United Kingdom: 24 April 2014: UK NICE does not recommend breast cancer drug Kadcyla in draft guidance).