Russia's draft Vital and Essential Drugs List for 2012 has been published, including a good number of new innovative drugs, with the oncology therapeutic area strongly represented.
IHS Global Insight Perspective | |
Significance | A good number of high-cost innovative oncology drugs are included among the new innovative products on the draft Russian Vital and Essential Drugs List for 2012, published recently by the Ministry of Health and Social Development. |
Implications | This represents a continuation of the growing importance of high-cost innovative drugs within the Russian market, as the Russian authorities dedicate increasing resources to drug reimbursement. |
Outlook | The attractiveness of Russia as a growth market for multinational innovative pharmaceutical companies is set to grow as the country's reimbursement policies evolve to include greater numbers of innovative products. |
New Draft Essential Drug List Published
The Ministry of Health and Social Development of the Russian Federation has published its new draft Vital and Essential Drug (ZHNVLP) List for 2012, which includes as many as 24 new therapeutic agents (active ingredients) that had previously not been included on the list. The ministry reveals that of the 567 products on the list, some 94 (16.7%) are produced by Russian manufacturers, while 35.9% are produced by foreign manufacturers, and 47.4% by both Russian and foreign companies. The full list is available, in Russian, here.
The draft ZHNVLP List has been compiled using the unified international Anatomical Therapeutic Chemical classification system, taking into account the mechanism of action and chemical structure of the drugs, as well as their pharmacotherapeutic groups.
A number of factors were taken into account in the drafting of the list, the ministry reports, in accordance with recommendations from the World Health Organization. These included the presentation of scientific data on safety and efficacy, and evidence of clinical efficacy at level B of the Oxford classification—meaning confirmed efficacy and safety in one or more randomised clinical trials—or on the basis of a number of years of positive clinical experience within public health systems.
New Innovative Oncology Drugs and Indications Feature Strongly on Draft List
Among the new therapeutic agents included on the draft list, new innovative oncology drugs and new indications for these feature strongly. Thus, US firm Eli Lilly's oncology drug Alimta (pemetrexed) is included for the treatment of non-small-cell lung cancer (NSCLC) and malignant pleural mesothelioma, and UK pharma company AstraZeneca's Iressa (gefitinib) is also included for the treatment of NSCLC. Among several non-oncology additions, Swiss pharma major Novartis benefits from the addition of its neovascular age-related macular degeneration (AMD) drug Lucentis (ranibizumab), as well as Afinitor (everolimus), indicated for the prevention of transplant rejection in kidney and heart transplant patients.
Selected New Innovative Drugs Included in Draft 2012 ZHNVLP List | ||
Name of Drug | Producer | Indications |
Alimta (pemetrexed) | Eli Lilly | NSCLC, malignant pleural mesothelioma |
Iressa (gefitinib) | AstraZeneca | NSCLC |
Sprycel (dasatinib) | Bristol-Myers Squibb (BMS, US) | Chronic myeloid leukemia (CML), Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) |
Tasigna (nilotinib) | Novartis (Switzerland) | CML, Ph+ ALL` |
Nexavar (sorafenib) | Bayer (Germany) | Metastatic renal cell carcinoma (RCC), primary liver cancer |
Sutent (sunitinib) | Pfizer (US) | RCC, gastrointestinal stromal tumours |
Revlimid (lenalidomide) | Celgene (US) | Multiple myeloma in patients who have received at least one line of therapy |
Atriance (nelarabine) | GlaxoSmithKline (UK) | T-cell ALL, T-cell lymphoblastic lymphoma |
Erbitux (cetuximab) | Merck Serono (Germany) | Metastatic colorectal cancer, squamous cell carcinoma of the head and neck |
Lucentis (ranibizumab) | Novartis | Neovascular AMD |
Afinitor (everolimus) | Novartis | Prevention of transplant rejection in adult recipients of heart and kidney transplants |
Orencia (abatacept) | BMS | Moderate-to-severe rheumatoid arthritis and juvenile idiopathic arthritis |
Source: Russian Ministry of Health and Social Development | ||
Outlook and implications
The expansion of the ZHNVLP list to incorporate such a large number of new innovative drugs—particularly in the field of oncology—is a testament to the increasing willingness of the Russian authorities to invest larger amounts in the reimbursement of medicines (including high-cost innovative ones) for its citizens, although the coverage of these drugs remains quite limited across the Russian Federation. It comes at a time when an increasing number of the companies that are benefiting from the inclusion of their drugs on the ZHNVLP list are choosing to set up production and/or development operations in Russia, and this is no coincidence; Russia's authorities are very much in favour of international pharmaceutical companies establishing manufacturing bases in the country, and those that do certainly gain a competitive advantage.
With an increasing level of drug reimbursement expenditure in Russia for high-cost, innovative treatments, both in the case of the ZHNVLP and the "7 Nosology" list (see Russia: 22 September 2011: Russian Healthcare Law Amendments Will Increase Orphan Drugs Access; Debate on Drug Insurance Provision Continues), the attractiveness of the Russian market for multinational pharmaceutical companies—from the perspective of its status as a growth market—is set to be enhanced.