Market Access

Datamonitor Malignant Melanoma Pricing and Reimbursement

Malignant Melanoma Pricing, Reimbursement and Access

This strategy report focuses on Malignant Melanoma Pricing and Reimbursement including how immunotherapies are changing melanoma treatment paradigms with market conext in the US, Japan, and five major EU markets.

September 30, 2015

US Regulatory Issues

Key regulatory developments include the new Prescription Drug User Fee Act (PDUFA-V), which aims to improve interaction between the FDA and drug developers.

Japan Regulatory Issues

Historically Japan has been plagued with delays, with new drug approvals sometimes taking three or four years longer than in the US and EU.

UK Regulatory Issues

Recently there have been several new regulatory changes in the UK aimed at reducing the regulatory burden and allowing earlier access to medicines which are seen as a positive development for the pharmaceutical industry.

US Healthcare System Overview

Continued growth in healthcare expenditure and the high number of individuals without health insurance coverage were the key drivers of the passage of the healthcare reform law.

Asthma Pricing, Reimbursement, and Access

The next wave of key therapies in asthma includes biologics, with interleukin (IL)-5 inhibitors first to reach the market.

Multiple Myeloma Pricing, Reimbursement, and Access

Highlights: The budget impact of multiple myeloma is set to increase While multiple myeloma represents a relatively small patient population in comparison to other cancers, payers are concerned about the rising spend on the indication. New biologic therapies are increasingly gaining label expansions in earlier treatment lines, and with life expectancies improving, patients are requiring […]

March 5, 2019

prostate-cancer-pricing-reimbursement-and-access_162106_10-2016

Prostate Cancer: Market Access Pricing & Reimbursement

The prostate cancer market has become saturated in the metastatic castration-resistant prostate cancer (CRPC) setting; the approval of second-generation antiandrogens, radiotherapies, and chemotherapies has resulted in a great deal of development targeting earlier stages of the disease.

June 1, 2018

Psoriatic Arthritis: Market Access Pricing & Reimbursement

Tumor necrosis factor (TNF)-alpha inhibitors Enbrel, Humira, and Remicade have long held dominant positions in the psoriatic arthritis market.

Key Trends in BRICMIST Market Access

Brazil, Russia, India, China, Mexico, Indonesia, South Korea, and Turkey – known collectively as the BRIC/MIST countries – have been a source of welcome growth for a pharmaceutical industry struggling to generate significant gains in its traditional core markets.

CER, HEOR, and Value-Based Frameworks in the US

It is no secret that Americans spend heavily on healthcare – in 2013, US healthcare expenditure totaled nearly $3bn ($9,255 per person) and accounted for 17.4% of gross domestic product.

Psoriasis Pricing, Reimbursement, and Access

Launch of multiple IL inhibitors with impressive efficacy has significantly reduced unmet need in the disease, and also provided payers with leverage in price negotiations as they seek to control growing treatment cost.

March 28, 2019

Turkey Regulatory Issues

The mandatory requirement imposed by the Turkish authorities for overseas manufacturers exporting pharmaceutical products to Turkey to obtain Good Manufacturing Practice (GMP) certification issued by the Turkish Ministry of Health is causing inordinate delays in the registration of new pharmaceutical products in Turkey. However, these delays can be resolved once the US Food and Drug […]

November 1, 2016

India Regulatory Issues

The drug approval process in India is not complex, although poor patent protection and government policies favoring generic companies make multinational companies (MNCs) wary of launching new drugs in the country.

November 1, 2016