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

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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

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Chronic Obstructive Pulmonary Disease (COPD): Market Access Pricing & Reimbursement

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Long-acting beta 2 agonist/long-acting muscarinic antagonist (LABA/LAMA) combination inhalers have been gaining traction due to an expanding evidence base for their wider use, and competitive pricing.

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

Indonesia Regulatory Issues

Challenges for foreign pharma companies in relation to Indonesia’s pharma system include lengthy and variable approval periods, compulsory licenses, and counterfeits.

Indonesia Healthcare System Overview

With only 2.6% of GDP spent on healthcare in 2010, the healthcare system in Indonesia has huge potential for growth.

Germany Regulatory Issues

Data indicates that companies often favor Germany when choosing a reference member state (RMS) in order to gain approval under the decentralized procedure, perhaps reflecting overall a fast pace of regulatory review.

US Pricing and Reimbursement

Historically, few pricing controls have been implemented in the US; however, there is greater pressure to implement controls to help contain costs associated with the expansion of public healthcare provision.

Germany Pricing and Reimbursement

The German pharmaceutical market has historically been the most attractive European market due to high prices and high drug utilization. However, this is changing, with comparability assessment requirement raising the bar for achieving a higher price point.

France Regulatory Issues

The much-criticized delay in the removal of marketing authorization for Servier’s Mediator in France has had profound implications for reform of the country’s regulatory system.

Germany Healthcare System Overview

Already high and rising healthcare expenditure coupled with unfavorable demographic dynamics are prompting the German government to introduce changes in order to ensure healthcare system sustainability.

France Healthcare System Overview

France spent more of its gross domestic product (GDP) on healthcare in 2010 than the average of other key developed markets.

Access in Emerging Markets: HTA is Making Inroads

Generally considered the domain of developed markets, health technology assessment (HTA) is increasingly being used by developing countries as a means of reconciling growing demand for access to health technologies with limited resources. Expanding public health insurance programs, coupled with aging populations and growing patient empowerment, have led in some cases to the fast establishment […]

Argentina Regulatory Issues

With a growing economy and 40 million inhabitants, Argentina is one of the most important emerging market destinations in South America.

UK Healthcare System Overview

Reform of the NHS is underway despite widespread controversy and opposition from physicians, and will necessitate a change in the way pharmaceutical companies work with key stakeholders.

Spain Healthcare System and Drug Regulatory Analysis

The market environment in Spain is extremely challenging, with cost-containment measures introduced in 2010–12 contributing to an overall reduction in pharmaceutical spending.

India Pharmaceutical Market Dynamics

India is one of the most important emerging pharmaceutical markets, and the market is forecast to more than double between 2011 and 2017, growing at a compound annual growth rate of 16.1%.

EGA Biosimilars Conference 2015

With the entry of the first monoclonal antibody biosimilar in most European markets and approval of the first biosimilar in the US, 2015 promises to be a landmark year for the biosimilars market. The savings potential of biosimilars in a time of constrained healthcare budgets is an attractive value proposition for many payers, and regulators’ positive stance in terms of making the approval and development process as efficient as possible is advantageous for the sector.