Market Access

Value-Based Pricing – Evolution Rather Than Revolution

$5,000.00

A new value-based assessment (VBA) process is scheduled to come into effect in the UK in late 2014. There have been significant delays in determining how this would work in practice, reflecting VBA’s complexity.

Vaccines Market Access in Emerging Markets

$3,000.00

Emerging markets account for approximately 18% of the global vaccines market, which is valued at more than $24bn. However, there are indications that this is an underestimate, and some observers forecast that the overall marketplace will reach $50bn by the mid2020s.

August 29, 2019

US Specialty Drug Market Access

High-touch specialty drugs for complex, chronic, high-cost, or rare diseases are an increasingly significant component of the US pharmaceutical market. A sharp growth in regulatory approvals accompanied by high prices has driven rapid increases in expenditure on specialty therapies by both public and private payers.

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.

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.

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.

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.

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.

UK Generics and Biosimilars

Prescribing by international non-proprietary name, pharmacist incentives, and the high price differential between the brands and their generic alternatives are the key drivers of the generics market in the UK.

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

Turkey Pricing and Reimbursement

To contain overall healthcare expenditure and to rein in the rapid growth of pharmaceutical expenditure, in 2004 Turkey introduced price-setting procedures using an external reference system based on 5–10 reference countries (all from the EU).

Trends in CNS Dealmaking, 2012–16

Diseases of the central nervous system (CNS) offer considerable opportunity to drug developers and marketers.

August 8, 2017

The Growing Impact of Real-World Evidence

Real-world evidence (RWE) has become increasingly important in proving the value of drugs and differentiating them from their competition.

July 14, 2017

The Evolution of Pharmaceutical Sales Strategies Continues

Pharmaceutical sales forces have evolved from the traditional structure, which was dominated by considerable numbers of field-based representatives detailing a range of products to different physicians on a regular basis.

November 1, 2016

Spotlight on Antibody-Drug Conjugates

The first antibody-drug conjugate (ADC), Mylotarg, reached the market almost two decades ago. Since this time, the ADC field has undergone slow but transformative enhancements, with improvements to technologies and advancements in the pipeline leading to an invigoration of the field. The past couple of years have seen the approvals of three new ADCs: Polivy, Lumoxiti, and Besponsa, increasing the total number of ADCs approved by regulators worldwide to six. These approvals mark the start of a new era in which the ADC field is finally beginning to realize its full potential. With the ADC pipeline swelling to around 250 novel candidates in various stages of preclinical and clinical development, approvals for more ADCs appear firmly on the horizon.

September 20, 2019

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.

Russia Pharmaceutical Market Dynamics

With the Russian economy recovering from the recession experienced in 2009, the pharmaceutical market has also returned to growth.

Russia Generics and Biosimilars

Despite high volume uptake, generics still account for only a small proportion of the total market value in Russia, driven by a lack of incentives for generic substitution and the significant originator/generic price differential.

November 3, 2016

Renal Cell Cancer Pricing, Reimbursement, and Access

There is moderate concern among payers regarding spend on renal cell cancer (RCC) drugs, but access restrictions remain mild.

August 22, 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.

October 17, 2016

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

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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

Poland Pricing and Reimbursement

The average drug price in Poland is the lowest in the EU, mainly due to the high proportion of generic pharmaceuticals, low availability of innovative drugs, and high price pressure on reimbursed drugs.

Ovarian Cancer Pricing, Reimbursement, and Access

Ovarian cancer medicines have traditionally been subject to low restrictions, as most patients usually start and remain on inexpensive platinum-based therapies. However, beginning with the launch of vascular endothelial growth factor inhibitor Avastin, followed by poly (ADP-ribose) polymerase (PARP) inhibitor Lynparza, payers are seeing an uptick in spend for the indication.

March 5, 2018

Orphan Drug Pricing and Reimbursement

Orphan drugs account for a growing portion of payers’ budgets – and comprise some of the most expensive treatments available.

Orphan Drug Access and Pricing in Emerging Markets

This analysis covers the four major emerging regions of the Middle East and Africa, Latin America, Eastern Europe, and Asia-Pacific. Within these regions, relatively wealthier markets with a proven marketplace for orphan medicines have been prioritized.

January 12, 2018

NOACs Pricing, Reimbursement, and Access

A combination of the high cost of novel oral anticoagulants (NOACs) (relative to highly genericized vitamin K antagonists) and the large patient populations these drugs address, has resulted in this class of compounds being a top priority for European payers.

May 10, 2017

New Pharma Models for a New Healthcare Era

This analysis includes insights from eight interviewed experts from pharma, medical device, or digital health companies.

December 20, 2018

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