Murray Aitken

Progress in cell biology, genetics, molecular, and systems pharmacology is the driving force behind a current paradigm shift in drug research. This paradigm shift shapes new avenues for advanced treatments that are commonly referred to as ‘systems therapeutics’. Systems therapeutics differ in many ways from current drugs because they target biological networks rather than single transduction pathways, and affect disease processes rather than physiological processes. Here, we examine how the… Show more

Progress in cell biology, genetics, molecular, and systems pharmacology is the driving force behind a current paradigm shift in drug research. This paradigm shift shapes new avenues for advanced treatments that are commonly referred to as ‘systems therapeutics’. Systems therapeutics differ in many ways from current drugs because they target biological networks rather than single transduction pathways, and affect disease processes rather than physiological processes. Here, we examine how the paradigm shift towards systems therapeutics will change current scientific concepts of the interactions between drugs and diseases, the organization of research and development, as well as the clinical use and therapeutic evaluations of therapeutic interventions. Show less

With the imminent arrival of oncology biosimilars in the therapeutic paradigm, stakeholders including a clinician, specialist nurse, patient advocate, regulator and economist provide their perspective on optimising the uptake of these new agents in the treatment of cancer. A number of key messages emerge, based on the discussion that took place during a session of the European Society for Medical Oncology’s Annual Congress, ESMO Madrid 2017. First, for successful integration of biosimilars into… Show more

With the imminent arrival of oncology biosimilars in the therapeutic paradigm, stakeholders including a clinician, specialist nurse, patient advocate, regulator and economist provide their perspective on optimising the uptake of these new agents in the treatment of cancer. A number of key messages emerge, based on the discussion that took place during a session of the European Society for Medical Oncology’s Annual Congress, ESMO Madrid 2017. First, for successful integration of biosimilars into the global healthcare paradigm, informing and educating the full scope of stakeholders, including clinicians, nurses, pharmacists and patients, is primordial. Success is dependent on providing solid evidence and ensuring all voices are heard. Second, for oncology medicines, much can be learnt from the growing experience of approved biosimilars in other disease indications, with success stories for patients, their healthcare providers and healthcare budgets alike. Finally, effective sustainability of the impact on healthcare budgets and the redirection of these savings require education and transparency. Show less

The sales and financial returns realized by pharmaceutical companies are a frequent topic of discussion and debate. In this study we analyzed the economic returns for four cohorts of new prescription drugs launched in the United States (in 1991–94, 1995–99, 2000–04, and 2005–09) and compared fluctuations in revenues with changing average research and development (R&D) and other costs to determine patterns in rewards for pharmaceutical innovation. We found that the average present values of… Show more

The sales and financial returns realized by pharmaceutical companies are a frequent topic of discussion and debate. In this study we analyzed the economic returns for four cohorts of new prescription drugs launched in the United States (in 1991–94, 1995–99, 2000–04, and 2005–09) and compared fluctuations in revenues with changing average research and development (R&D) and other costs to determine patterns in rewards for pharmaceutical innovation. We found that the average present values of lifetime net economic returns were positive and reached a peak with the 1995–99 and 2000–04 new drug cohorts. However, returns have fallen sharply since then, with those for the 2005–09 cohort being very slightly negative and, on average, failing to recoup research and development and other costs. If this level of diminished returns persists, we believe that the rewards for innovation will not be sufficient for pharmaceutical manufacturers to maintain the historical rates of investments needed to sustain biomedical innovation. Show less

We examine six molecules facing initial loss of US exclusivity (LOE, from patent expiration or challenges) between June 2009 and May 2013 that were among the 50 most prescribed molecules in May 2013. We examine prices per day of therapy (from the perspective of average revenue received by retail pharmacy per day of therapy) and utilization separately for four payer types (cash, Medicare Part D, Medicaid, and other third party payer – TPP) and age under vs. 65 and older. We find that quantity… Show more

We examine six molecules facing initial loss of US exclusivity (LOE, from patent expiration or challenges) between June 2009 and May 2013 that were among the 50 most prescribed molecules in May 2013. We examine prices per day of therapy (from the perspective of average revenue received by retail pharmacy per day of therapy) and utilization separately for four payer types (cash, Medicare Part D, Medicaid, and other third party payer – TPP) and age under vs. 65 and older. We find that quantity substitutions away from the brand are much larger proportionately and more rapid than average price reductions during the first six months following initial LOE. Brands continue to raise prices after generics enter. Expansion of total molecule sales (brand plus generic) following LOE is an increasingly common phenomenon compared with earlier eras. The number of days of therapy in a prescription has generally increased over time. Generic penetration rates are typically highest and most rapid for TPPs, and lowest and slowest for Medicaid. Cash customers and seniors generally pay the highest prices for brands and generics, third party payers and those under 65 pay the lowest prices, with Medicaid and Medicare Part D in between. The presence of an authorized generic during the 180-day exclusivity period has a significant impact on prices and volumes of prescriptions, but this varies across molecules. Show less

We examine market share and price trends in the quarter century since the 1984 Waxman-Hatch legislation. The generic share of US retail prescriptions has grown from 18.6% in 1984 to 74.5% in 2009, with a notable acceleration in recent years. Whereas in 1994 the generic price index fell from 100 to 65 in the 24 months following initial generic entry, in 2009 the comparable price index was 28. For the prescription drugs most commonly used by beneficiaries in Medicare Part D, rather than… Show more

We examine market share and price trends in the quarter century since the 1984 Waxman-Hatch legislation. The generic share of US retail prescriptions has grown from 18.6% in 1984 to 74.5% in 2009, with a notable acceleration in recent years. Whereas in 1994 the generic price index fell from 100 to 65 in the 24 months following initial generic entry, in 2009 the comparable price index was 28. For the prescription drugs most commonly used by beneficiaries in Medicare Part D, rather than increasing by 25–28% as has been reported by the American Association of Retired Persons (focusing entirely on brand prices), we find that once one incorporates substitution to lower priced generics following patent expiration, average price per prescription fell by 21.3% from 2006–09. Finally, we find that the weighted mean reduction in pharmaceutical daily treatment cost across nine therapeutic areas equaled 35.1% at 24 months post-generic entry Show less

While much has been written about the distinctions between biologics and small molecules in terms of their scientific, manufacturing and regulatory experiences, relatively little has been published comparing their clinical and commercial experiences. Employing a data base encompassing all 96 biologics and 212 small molecules newly launched in the U.S. between 1998Q1 and 2008Q4, we compare their downstream clinical and commercial characteristics. Substantial heterogeneity occurs across… Show more

While much has been written about the distinctions between biologics and small molecules in terms of their scientific, manufacturing and regulatory experiences, relatively little has been published comparing their clinical and commercial experiences. Employing a data base encompassing all 96 biologics and 212 small molecules newly launched in the U.S. between 1998Q1 and 2008Q4, we compare their downstream clinical and commercial characteristics. Substantial heterogeneity occurs across therapeutic classes. Biologics are more concentrated than small molecules in their therapeutic class composition, but have obtained FDA indication approvals in 13 of 15 classes. While average delays between FDA approval and first observed sales revenues are similar, biologics are twice as likely as small molecules to be Orphan Drugs, are slightly more likely to be designated FDA priority rather than standard review status, and gain slightly more supplemental indication approvals. Although 9.4% of new small molecules permanently exited the market for a variety of reasons, 7.3% of new biologics exited, but 26% of biologics had black box warnings compared to 20% of small molecules. Both biologics and small molecules take 21-22 quarters from launch to reach $100 million in real revenues. Small molecules have an initially more rapid uptake, but thereafter biologics’ mean revenues tend to be slightly greater than for small molecules. While launch prices for biologics are commonly perceived as being greater than for small molecules, price growth per standard unit is generally greater for small molecules than biologics, with rates of price growth increasing for small molecules in the first five years since launch, and decreasing thereafter. We conclude that the market dynamics of biologics differ substantially from those of small molecules, although therapeutic class composition plays a major role. Show less

Annual growth in real prescription drug spending averaged 9.9 percent during 1997–2007 but has slowed since 2003, falling to 1.6 percent in 2007. More patent expirations, increased generic penetration, and reduced new product innovations have contributed to this turning point. We document trends and identify underlying components: declines in the role of blockbuster drugs, increased importance of biologics and vaccines relative to traditional pharmaceuticals, and a changing medication mix away… Show more

Annual growth in real prescription drug spending averaged 9.9 percent during 1997–2007 but has slowed since 2003, falling to 1.6 percent in 2007. More patent expirations, increased generic penetration, and reduced new product innovations have contributed to this turning point. We document trends and identify underlying components: declines in the role of blockbuster drugs, increased importance of biologics and vaccines relative to traditional pharmaceuticals, and a changing medication mix away from those prescribed principally by primary care physicians toward those mostly prescribed by specialists. We conclude with policy implications. Show less