Blog

bringing ultra-orphan drugs to marke
Ultra-orphan drugs and NICE
  • September 22, 2017
  • Steve Bradshaw

March 2017 saw the National Institute for Health and Care Excellence (NICE) board, with input from the NHS England Specialised Services Commissioning Committee, agree to a change that will have a substantial impact on both patients and the companies bringing ultra-orphan drugs to market. In this article we consider what is going to change and […]

Biobetters: Market access opportunity?
  • July 14, 2017
  • James Wright

Biobetters are biologics that have been improved compared to the marketed originator, for example in efficacy, safety, tolerability or dosing regimen. For regulatory approval, biobetters must meet the same data requirements as all other originator products, whilst only a reduced clinical data package is needed for biosimilars (Table 1). This produces time pressure for biobetters […]

Outcomes-Based Pricing
Enabling market access through outcomes-based pricing
  • May 25, 2017
  • Valid Insight

With the need to contain healthcare costs, payers often adopt selection criteria aimed at limiting the brands that are reimbursed and the price of those products. In some cases focus on cost containment can compromise patient access to new and innovative treatments. The need to establish a balance between cost containment and patient access pushes […]

Launch Factory
Launch factory: Improving market access to new therapies
  • May 12, 2017
  • Valid Insight

Getting the launch right for a new therapy can ensure market access and long-term success.1 However, product launching can be a big challenge for pharmaceutical companies due to many factors, such as high development costs, increasing competition, more stringent government and regulatory restrictions, and drug patent expirations.2

Valid Insight Market Access
Cell and gene therapy: Are payers willing to pay for a cure?
  • May 5, 2017
  • Dominic Jones-Phillips

Finding a cure for debilitating conditions is a long-standing aspiration for many working within the pharmaceutical industry. Indeed, when news broke out of a 15-year-old boy with Sickle Cell Anaemia experiencing 15 months without symptoms and routine treatment,1 interest in the curative potential of the novel gene therapy administered to the teenager increased. However, the […]

Orphan Drug Market Access
Ensuring orphan drug access amidst a more challenging environment
  • April 19, 2017
  • Valid Insight

Thomas Mueller, Head of Pharmaceuticals at the Federal Joint Committee (G-BA), stated at the Pharma Pricing and Market Access Congress in London, February 2017, that the association of orphan drug status with high prices cannot continue and that the only way for orphan drug pricing to go is down. Yet, due to the small target […]

Challenging market access barriers for autoimmune disease therapies
  • April 10, 2017
  • Valid Insight

The global immunology market is expected to grow from $61.5 billion in 2015 to more than $74 billion by 2022.1 Autoimmune diseases, such as diabetes and rheumatoid arthritis, require life-long treatment and constitute one of the largest spending areas in healthcare. The prevalence of autoimmune diseases is also increasing annually.2 Clearly, this is a lucrative […]

Market access immuno-oncology
Improving market access to immuno-oncology therapies
  • April 4, 2017
  • Valid Insight

The number of unmet needs, whether clinical, economic or humanistic, remains high in oncology, especially for patients with metastatic conditions. With positive clinical trial results in many cancer types, including melanoma, colon cancer, lung cancer, Hodgkin’s disease, leukaemia, and others, immuno-oncology therapies are offering patients a new treatment alternative.1 Interest in immuno-oncology has been piqued […]

Market Access
Navigating the future of oncology market access
  • March 29, 2017
  • Valid Insight

According to many payers, the high prices of oncology medicines are not sustainable and there remains a gap between drug price and value.1 The rising costs of drug development, increased clinical demand and the need to recoup the cost of failed products, have led to new cancer treatments that come with a high price tag. […]

Payer-centric post-launch studies for optimal negotiations
  • March 13, 2017
  • Valid Insight

Many healthcare stakeholders want to ensure better health outcomes for patients. However, many new and innovative therapies enter the market with evidence gaps in their value proposition. Since tracking and measuring outcomes entails cost and time, many payers decide to go with simpler and more straightforward financial-based contracting agreements, such as discounting, price-volume agreements, and […]