New research suggesting that despite generics, good opportunities are arising for new antidepressants, is research that Steven Bradshaw believes could prove pivotal going forward.
Dr Steven Bradshaw, International Healthcare Policy Expert
Dr Steven Bradshaw is an expert on international healthcare policy. In this capacity, Bradshaw uses his industry experience to act in an advisory capacity to some of the world’s most prominent pharmaceuticals chains and government think tanks.
As such, Bradshaw often comments on the healthcare issues of the day. Often Bradshaw’s observations over the deeper issues facing the international healthcare sector i.e. his recent commentary on the blurred lines of ethical publishing, provides the pharmaceuticals industry with fresh insight into its most complex issues. That is why Bradshaw felt he must comment this week on this new research.
Impact of Genericisation on Unipolar Market Reduced by Novel Antidepressants?
According to Pharmatimes, new research has been released suggesting that the impact of genericisation on the unipolar depression market could be reduced by the ongoing uptake of novel antipsychotics and antidepressants.
Specifically, the research from Decision Resources, suggests that the growing use of two therapies that have recently been approved – Actavis/Pierre Fabre’s Fetzima (levomilnacipran ER) and Lundbeck/Takeda Pharmaceutical’s Brintellix (vortioxetine), along with soon to be launched Otsuka Pharmaceutical/Lundbeck’s brexpiprazole, will act to negate a steep near-term decline in sales spurred by the expiring patents for two essential treatments attributed to unipolar depression. These are Bristol-Myers Squibb/Otsuka Pharmaceutical’s Abilify (aripiprazole) and Eli Lilly/Shionogi’s Cymbalta/Xeristar (duloxetine).
What Will Happen When Current Treatments Aren’t Enough?
The research further found that it believes emerging antidepressant therapies will be ascribed to patients as third and fourth line treatments. The research elaborated by saying that it believes this will be the case for patients whose depressive symptoms are not effectively met by generic selective serotonin and norephinephrine reuptake inhibitors (SNRIs) as well as serotonin reuptake inhibitors (SSRIs), along with patients known to hold low tolerance thresholds for the therapies currently available.
Furthermore, the study suggested that in the absence of more effacious options, it sees evidence to suggest that the use of atypical antipsychotics as adjunctive treatment in patients known for their minimal responses to antidepressants, will continue to grow. Particularly, the launch of generic aripiprazole during the period of examination will by 2023, see greater use of the treatment in this manner.
Brintellix Will Witness a Modest Uptake
Meanwhile, the research went on to find that Brintellix will witness a modest uptake in the role of a later-line option in the treatment of non-responders during the forecasted period.
Detailed trial data has provided evidence to suggest that the drug has a significant advantage over other antidepressants, because it may foster improvements in cognition. Furthermore, it boasts a low risk of sexual dysfunction and weight gain. DR went on to conclude that the relatively high price of Brintellix will spur its peak-year sales in key markets, to a forecasted $2.4 billion by the year 2022, even as a later-line treatment.
Decision Resources Clarifies Their Findings
DR went on to say that despite increasingly restrictive reimbursement cultures in most major international sectors, and the extensive generic availability of antidepressants used for early-line treatment, there are still opportunities to be had for novel antidepressants. This is because of the fact that a large share of the drug-treated populace reacts suboptimally to available monoaminergic-targeted drugs.
It further forecasted that the use of generics Abilify and Cymbalta/Xeristar will not only lead to a dramatic drop in sales in the near-term – because of the quick uptake and extensive use of generics – but will also foster market access pressure for emerging agents planning to launch in these classes – Brexpiprazole and Fetzima respectively.
Decision Resources Group Analyst Alana Simorellis Speaks Out
Group Analyst Alana Simorellis at Decision Resources spoke out on the study. Simorellis suggested that treatment-resistant depression has and should continue to be the area of largest unmet need as far as treatment of the condition goes throughout the next decade.
Simorellis went on to say that “an agent proven to be more effective than current agents in treatment-resistant patients would be welcomed by physicians and would likely be used as part of combination therapy.”
Dr Steven Bradshaw Comments
In Steven Bradshaw’s opinion, Simorellis makes a prudent point. An agent that has been proven to be more effective would be welcomed by the entire healthcare industry. However, clinical trials in depression are challenging. There are known difficulties in assessing severity and limitations of clinical rating scales and the placebo effect. Changes to clinical trial design and developing multidimensional endpoints, or allowing for introduction of composite measures in which objective markers of disease could be used as endpoints could help to solve these issues. Whether the ongoing uptake of novel antidepressants does replace genericisation in the treatment of the condition, as the study suggests, only time will tell and it is important to remember that from the perspective of those who hold the purse strings, generics are all so much cheaper.