| ViiV Healthcare |
49702024613 |
DOVATO TAB 50-300MG |
2019-04-23 |
2295.0000 |
None |
1 |
None |
None |
None |
None |
None |
None |
None |
Regarding Marketing/Pricing Plan Description, ViiV has not released DOVATO's marketing or pricing plan information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). Regarding estimated number of patients in the US that may be prescribed DOVATO, ViiV has not released this information in the public domain and is limiting its response to that which is publicly available pursuant to California Code of Regulations, Title 22, Division 7, Chapter 9.5 Section 96076(c). DOVATO was not granted breakthrough therapy designation or priority review by the federal Food And Drug Administration. Note on Acquisition Fields: This drug was developed by ViiV Healthcare, therefore the following fields related to drug acquisition have been left blank: ACQUISITION_DATE, ACQUISITION_PRICE, ACQUISITION_PRICE_NONPUBLIC, ACQUISITION_PRICE_COMMENT. |
None |
| Vertex Pharmaceuticals |
51167033101 |
TRIKAFTA™ (elexacaftor 100 mg, tezacaftor 50 mg, ivacaftor 75 mg per tablet and ivacaftor 150 mg per tablet) is supplied as an 84-count tablet carton containing a 28-day supply (4 weekly wallets, each with 21 tablets). |
2019-10-25 |
23896.1300 |
MARKETING PLAN: Vertex’s commercial field team in the United States is composed of a small number of individuals, and we focus our United States marketing activities for TRIKAFTA™ towards a limited number of physicians and health care professionals who are located at Cystic Fibrosis (CF)-focused accredited centers in the United States. The objective of these activities is to raise awareness and understanding about the approved indication, dosing, efficacy and safety data that are consistent with TRIKAFTA’s FDA approved label. Specific activities related to physicians and health care professionals include print distribution by the commercial field team to CF care centers, digital advertising (e.g., TRIKAFTA’s product website), and other educational programs. Specific activities related to people living with CF and their caregivers include print distribution of patient materials to CF care centers and digital advertising (e.g., TRIKAFTA’s product website and social media pages). Vertex does not engage in traditional direct-to-consumer advertising (e.g., television or mass media). Vertex also operates a comprehensive patient support program, known as Vertex Guidance & Patient Support (Vertex GPS™), which helps eligible patients who have been prescribed TRIKAFTA (elexacaftor, tezacaftor, ivacaftor and ivacaftor), access their medication and help them stay on track with treatment. PRICING PLAN: At Vertex, our mission is ambitious: to discover medicines that can prevent, cure or fundamentally change the outcomes of serious diseases for patients and their families. Our pricing philosophy supports this mission and reflects the transformative clinical value of our medicines, our commitment to patient access and the investment required to bring new medicines to Cystic Fibrosis (CF) and other serious diseases. When determining the price of TRIKAFTA, we considered a combination of factors, including: • Efficacy of the medicine and the benefit to patients of treating the underlying cause of CF, therefore having the potential to modify the course of the disease • Ease for patients to access medicine • Impact on a serious orphan disease that places significant burden on the healthcare system and society • Commitment by Vertex to invest in the resources required to support the discovery and development of new medicines for those waiting for treatments and cures TRIKAFTA is a significant clinical advancement in the treatment of people with CF aged 12 years and older with at least one F508del mutation. The benefits and risks of TRIKAFTA were evaluated in two Phase 3 studies. In both studies, people taking TRIKAFTA experienced significant improvement in lung function and CF respiratory symptoms. • One study compared TRIKAFTA with an active comparator, tezacaftor/ivacaftor and ivacaftor, in people with two F508del mutations. The results showed a significant incremental improvement in lung function and CF respiratory symptoms in the people taking TRIKAFTA. • The other study compared TRIKAFTA with placebo in people with an F508del mutation and another mutation defined in the study. The results showed significant improvement in lung function, reduction in pulmonary exacerbations, and improvements in CF respiratory symptoms in the people taking TRIKAFTA. |
None |
17300 |
1 |
1 |
None |
None |
None |
None |
Based on patient registry data (2017), in the United States, up to 17,300 total patients aged 12 years and older may be eligible for treatment with TRIKAFTA™. |
https://reports.siera.oshpd.ca.gov/api/report/drug-pricing/attachment?id=330 |