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Why Pharma Need To Connect Better With Patient Organizations Now?

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A good number of patients (63%), especially those with chronic ailments would look for Patient Support Services, revealed a survey by Human Healthcare Systems, released on February 25, 2020. Alongside, drug companies are also, reportedly, investing billions of dollars in every year, for several types of patient support programs, according to the Fierce Pharma article of July 06, 2021, on this subject. It emphasized: ‘Pharma companies spend more than $5 billion on patient support programs every year.’

Thus, it will be interesting to explore – when patients are looking for Patient Support Services (PSPs) and pharma companies are also trying to deliver the same, what’s really happening on the ground? Today’s article will focus on this area to help pharma marketers to get a ringside view of this area, and take necessary action in this area to make this investment more productive.

The aim is to help create a cutting-edge marketing strategy, while delivering best patient value and outcomes in the new normal. Let me start by recapitulating what exactly is a PSP to ensure that we all are on the same page, during this discussion.

Patient Support Services (PSPs):

According to IQVIA, a key challenge in deliberating with PSPs is that they have broad definitions, and consequently, may often give rise to multiple interpretations, misunderstandings and even bias. Be that as it may, IQVIA defines PSP as ‘An umbrella term to describe initiatives led by pharmaceutical companies to improve access, usage, and adherence to prescription drugs. These programs can have a financial component, support clinical investments, focus purely on education, or a combination.’

As we also see around, such programs include – disease awareness campaigns, helping patients use their drugs at the right dose for the right duration for best outcomes, to help patients use their drugs with disease education, financial support and more.

Relevance of PSP in the new normal:

Although PSPs aren’t a new concept, studies unfold – value that PSPs deliver to the community is so significant that when created with a clear understanding of motivators and drivers of patient behavior, can fetch equally significant return on investments for the pharma players.

A recent IQVIA White Paper concludes by noting: ‘One of the major trends seen from the COVID-19 global pandemic, is an increase telehealth. As the point of enrolment into a patient support program goes digital, PSP programs need to adjust.’ This seismic shift in the way we seek and receive treatment will require companies to revisit and potentially update their actionable insight in this space, The paper further notes: ‘With an increase in digital enrolment there are now more opportunities to capture data points and utilize technology.’

Thus, I reckon, it will be worthwhile to fathom, when patients are looking for health care support services and pharma companies are also spending considerably towards the same, what exactly is happening on the ground.

Interestingly, according to the 2021 findings of Phreesia Life Sciences, which surveyed nearly 5,000 patients checking in for doctors’ appointments during the past February and March, found, ‘just 3% were using patient support programs (PSPs).’

Some key highlights of the survey findings:

The support programs in the above survey of Phreesia Life Sciences, broadly includes, services, such as, financial assistance, disease education and specifics about medicine – offered by pharma companies. Based on these, some of the key findings of the study were as follows: 

  • Just 3% of eligible patients are currently using support programs, and 8% have used them in their lifetimes.
  • 59% of patients have little to no knowledge of patient support programs.
  • 61% of patients feel that patient support programs of pharma companies would be “somewhat,” “a little,” or “not at all helpful” for them.
  • Most patients who had used support programs, used them either at first diagnosis, or when starting medication.
  • Only 10% of patients said they had learned about support programs online, but 44% said they’d like to learn about support programs online

Further, as one of the senior officials involved in this research, reportedly, said, ‘nine out of 10 qualified patients were not using the brand’s copay card—even though more than half (53%) said they would likely use one if they had it.’ Moreover, ‘two out of three patients reported it was the first time they were learning about it.’

Likely reasons for low usage of pharma’s PSPs: 

Some of the most likely reasons for low usage of pharma’s PSPs were deliberated in another article of Fierce Pharma dated December 04, 2020. A domain expert commented there, ‘pharma companies simply have missed the mark in developing useful, durable tools for patients. Elaborating this point further, she said, ‘Focusing just on specific adherence tasks, like medication reminders, isn’t providing enough value for patients over a long period of time.’

Another contributing factor could be, patients suffering from multiple diseases and those who are on multiple medications of different pharma companies, are unlikely to download four different apps to track each one.

One more reason could well depend on patients’ generally preferred sources to avail such services, which may not necessarily be pharma companies.

Patients generally preferred sources for patient services:

This point was discussed in the Accenture study – ‘Uniting pharma companies and patient organizations,’ published on August 07, 2019. This survey was done on 4000 patients and some broad findings of this study include the following:

  • Patients generally prefer services from patient organizations over those from pharma companies.
  • Patients feel that patient organizations have a better understanding of their emotional, financial, and other needs than many pharma companies.
  • Patients also want pharma companies to coordinate with patient organizations to provide better care.

The survey also captured details of patient preferences regarding availing required services from patient organizations, rather than the drug companies, as below:

  • Over 50% of patients have greater trust in and better experiences with patient organizations.
  • 64% of patients are willing to share their health data with patient organizations to get better care.
  • 52% of patients are willing to share their health data with patient organizations to get better care.
  • 72% of surveyed patients call or talk to someone at patient organizations on the phone.
  • 58% of patients attend in-person events hosted by patient organizations.

Are PSPs commercially useful to pharma companies?

The very fact that drug companies are currently spending over $5 Billion annually for PSPs, reflects their direct and indirect influence in pharma’s branding strategy and image building process. Otherwise, why would they spend so much? That said, the above survey details send a clear message to pharma marketers to maximize their marketing investments on PSPs, more than ever before. Consequently, the question arises, how to achieve that goal? 

Maximize marketing investments on PSPs:

Echoing and paraphrasing some points from the above IQVIA White Paper, let me highlight, especially for the marketers, 3 clear steps for maximizing returns from pharma’s investments on PSPs, as follows:

A. Gain beforehand deeper insights of patients’ PSP need and expectations: 

37% of patients surveyed said, pharma companies with actionable insights, will better understand their needs through collaboration with Patient Organizations (PO), leading to meaningful engagement in a more personalized way and more frequently.

B. Deliver patient expected value thorough close coordination with the POs:

This is because, 84% of patients think pharma companies – with closer coordination with, at least, a couple of influential patient groups or organizations (PO), will deliver greater value. This will also create a seamless and more cohesive patient experience, while filling gaps in the patient treatment process, to enhance end-to-end customer experience - in an unbiased way.

C.  Creating and delivering new and seamless patient experiences:

The newness is important – not just to delight the patients, but also for strategic differentiation in this ball game. This is possible by working closely with Patient Support Groups (PSGs) as partners, seeking ways to rethink for creating and delivering a unique patient experience from patients’ perspective, and outcome first basis.

Use of data, analytics and insights will be essential while creating care experiences that will better meet the patients’ needs, and would also help measure the impact of PSPs on an ongoing basis.

PSGs are helping to transform health care also in India:

Some PSGs are helping to transform healthcare with prudent use of PSPs in India, as they raise awareness about diseases, help people recover psychologically, and more, have been captured by Indian media, as well. One such report titled, How patient support groups are revolutionizing health care’ says: ‘Because of these networks, patients and their families have become better organized, and are equipped to handle emergency situations and advocate for access to treatment.’

Conclusion:

Echoing the ZS article, published on August 17, 2020, I too concur that COVID-19 has pushed the drug companies to define new ways to deliver care and reach patients. It is quite possible that patient organizations are moving faster in this direction than many pharma companies. Which is why, more patients, reportedly, prefer PSPs from patient organizations, over those from pharma companies.

Further, a course-correction in PSP, would also offer pharma marketers an additional opportunity. Because, PSPs have hidden potential to create an exceptional patient support base that marry brand’s key attributes with the new reality of patients, living with their conditions in the new normal.

Pharma companies will, therefore, need to move from typical reactive support programs – to delivering proactive patient experiences in a post-COVID-19 world, in partnership with PSGs. To ensure maximum number of patients use PSPs, it’s critical for pharma marketers to redefine – the “new normal” patient journey, and meet their current unmet needs in this space. That’s why, I reckon, to succeed in this ball game, pharma would need to effectively connect with patient organizations, more than ever before.

By: Tapan J. Ray  

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Gene Therapy Price: Commercial Viability And Moral Dilemma

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On May 24, 2019, Novartis announced the US-FDA approval of ‘the first and only gene therapy’ – Zolgensma, for a type of Spinal Muscular Atrophy (SMA), a lifesaving treatment for infants of less than 2 years of age. This unique drug halts disease progression with a single, one-time intravenous (IV) infusion.

On value offerings of Zolgensma,the Novartis CEO said: “The approval of Zolgensma is a testament to the transformational impact gene therapies can have in reimagining the treatment of life-threatening genetic diseases like spinal muscular atrophy. We believe Zolgensma could create a lifetime of possibilities for the children and families impacted by this devastating condition.”

Unquestionably, this development in medical science is indeed commendable. But, the jaw-dropping price tag – USD 2.125 millionattached to this product, has brought back gene therapy at the center stage of the incensed debate on access and affordability of such treatment for a vast majority of the population, across the world. Besides, two important issues related to gene therapy need to be effectively resolved – long-term commercial viability and the ‘moral dilemma’ that its market launch would prompt. And both are interconnected and also associated with the pricing rationale of such therapies.

I am terming  the second factor as a ‘moral dilemma’ rather than an ‘ethical dilemma’ because, “ethics is a more individual assessment of values as relatively good or bad, while morality is a more intersubjective community assessment of what is good, right or just for all.”In this article, I shall deliberate on these two interrelated issues. But, before delving into it, let me recapitulate in simple terms, what exactly is ‘Gene Therapy.’

What exactly is ‘Gene Therapy?’

According to US-FDA, human gene therapy seeks to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use.

Gene therapy is a technique that modifies a person’s genes to treat or cure disease. Gene therapies can work by several mechanisms:

  • Replacing a disease-causing gene with a healthy copy of the gene
  • Inactivating a disease-causing gene that is not functioning properly
  • Introducing a new or modified gene into the body to help treat a disease

Gene therapy products are now being studied to treat diseases including cancer, genetic diseases, and also infectious diseases.

Gene therapy price has been going higher than highest, thus far:

‘At USD 2.1 million, newly approved Novartis gene therapy will be world’s most expensive drug,’ says another report of May 24, 2019.It is noteworthy that Zolgensma price has been kept higher than the highest priced drug before this product came. If his trend continues, the future gene therapy cost is likely to exceed even Zolgensma price, the implication of which for patients who will need such treatment to save life or manage the disease, will be huge.

Intriguingly, the high treatment cost for a rare ailment like, SMA - a degenerative disorder that usually kills an infant within two years, is not limited to just gene therapy.  According to the April 04, 2019 article titled, ‘Biogen SMA drug price, Novartis estimates for its treatment far too high – U.S. group’ of Reuters, the price of another drug for SMA – Biogen’s Spinraza, which is not a gene therapy, is also very high. Its list price is USD 750,000 for the initial year and USD 375,000 annually. As reported, ‘Spinraza, an important growth driver for Biogen, took in USD 1.7 billion in 2018 sales.’

What should have been the actual prices of these drugs?

Interestingly, to determine the value of these drugs, the nonprofit Institute for Clinical and Economic Review (ICER) ‘used a measure known as “quality-adjusted life year” (QALY), in which each year of healthy or near-healthy life resulting from the treatment is worth USD 100,000 to USD 150,000.

Using the QALY benchmark, ICER, reportedly, said Spinraza should cost between USD 72,000 and USD 130,000 for the first year of treatment, and cost USD 36,000 to USD 65,000 per year after that, for infants not yet showing symptoms of the disease.

Further, with an alternative benchmark, known as life-year gained (LYG) based on the additional number of years a person lives due to a treatment, Spinraza is, reportedly, worth USD 83,000 to USD 145,000 in year one, and USD 41,000 to USD 72,000 annually thereafter, as ICER determined.

Zolgensma, on the other hand, would, reportedly, be worth USD 310,000 to USD 900,000 for Type 1 SMA patients based on the QALY assessment, and USD 710,000 to USD 1.5 million using the LYG calculation, ICER said.

Notwithstanding, whether one takes the QALY assessment or LYG based price of Zolgensma and Spinraza, the treatment cost of rare diseases, such as SMA for infants, is beyond the affordability of most people – whenever these drugs become the only choice to save lives. Thus, the question comes: Is gene therapy commercially viable or sustainable?

Is gene therapy commercially sustainable?

Undoubtedly, the development of gene therapy signifies yet another milestone in medical science to save lives, which is highly commendable. Nevertheless, the question arises, who will be able to afford this treatment? Thus, is development of gene therapy commercially viable and could be a money churner for a company on a long-term basis? There doesn’t appear to be a clear answer to these questions, just as yet. There are several reasons for this apprehension. But, I am citing below just two examples – related to their humongous treatment cost.

According to the article, published in the Scientific American, in the past five years, two gene therapy drugs have been approved in Europe and one in the United States. The name of this article is ‘Gene Therapy Is Now Available, but Who Will Pay for It?’ Interestingly, only three patients have so far been treated commercially with gene therapy, in Europe.

UniQure’s Glybera, used for a very rare blood disorder, costing around USD 1 million per patient, has been used just once since approval in 2012. However, in 2017, due to commercial reason UniQure decided to withdraw Glybera from the market. Similarly, Strimvelisof Orchard Therapeutics – used for severe Combined Immunodeficiency, costing USD 700,000, ‘has seen two sales since its approval in May 2016, with two more patients due to be treated later this year.’ Interestingly, these apprehensions have not deterred many companies. The ball keeps rolling.

But the ball keeps rolling:

That the ball keeps rolling, and at a faster pace, is evident from what US-FDA envisages in this field. According to US-FDA, by 2025, they are likely to approve 10 to 20 cell and gene therapy products a year. This is based on an assessment of the current pipeline and the clinical success rates of these products.

Importantly, despite apprehension of many, even some of the top pharma players, are fast moving into this space – based on their own assessment of the market. But, to move meaningfully in this direction, there are many several critical success factors, most of which are quite challenging and cost-intensive. A few of these, for example, are – a right collaborative model, ability to develop a scalable manufacturing process and overcoming various technical and regulatory challenges on the way. Interested pharma players, apparently, have realized these needs.

Big Pharma players joining ‘Gene Therapy’ bandwagon:

Big Pharma players, such as, Pfizer and Johnson & Johnson (J&J) have started moving into this space. Let me illustrate the point with just a couple of examples.

On March 20, 2019, Pfizer announced: ‘Pfizer has acquired a 15 percent equity interest in Vivet Therapeutics and secured an exclusive option to acquire all outstanding shares.’ Both the companies will collaborate on the development of Vivet’s proprietary treatment for Wilson disease – a rare and progressive genetic disorder, if remains untreated may cause liver (hepatic) disease, central nervous system dysfunction, and death.

Just before this, on January 31, 2019, Janssen Pharmaceutical of Johnson & Johnson (J&J) announced a worldwide collaboration and license agreement with MeiraGTx Holdings plc – a clinical-stage gene therapy company, to develop, manufacture and commercialize its clinical stage inherited retinal disease portfolio, including leading product candidates for achromatopsia. Even prior to this, on January 05, 2018, J&J had announced that the company has established an exclusive research collaboration with the University of Pennsylvania’s ‘Gene Therapy Program’ for fighting Alzheimer’s disease with gene therapy. There are several such instances of gene therapy collaboration for Big Pharma.

With a slightly different collaborative model for gene therapy, on April 12, 2018, GlaxoSmithKline (GSK) signed a strategic agreement to transfer rare disease gene therapy portfolio to Orchard Therapeutics, taking a 19.9 percent stake in the company and a seat on the board. Simultaneously, this agreement strengthens Orchard’s position as a global leader in gene therapy for rare diseases.

What could be the moral dilemma in gene therapy pricing?

The dilemma with gene therapy is that they are frightfully expensive, but at the same time is ‘life-transforming’ for many, across the socioeconomic spectrum. This could be another ‘moral dilemma,’ as such exorbitant, if not seemingly ‘vulgar pricing’, as it were, would raise many questions on the company’s own principles regarding right and wrongin saving lives of patients with its gene therapy.

The reason for this moral dilemma in, especially gene therapy pricing is aptly elucidated in an article titled, ‘How to pay for gene therapies in developing nations,’ published in  Evaluate Vantage on March 22, 2019. Admitting that discrepancies in healthcare between rich and poor nations are nothing new, the article also raises a flag, indicating: ‘The potentially curative nature of many gene therapies heightens the moral conundrum that companies will face if and when these projects get to market.

Acknowledging that gene therapies are hot right now, with their developers taking aim at everything from hemophilia to rare eye diseases prevalent in rich nations,the author raises a pertinent question: ‘With rich countries like the US finding it hard to fund gene therapies, it is worth asking whether these projects will ever reach patients in developing countries. And if they do how will companies cope?’

Intriguingly, to create a larger market some are also targeting disorders, largely seen in poorer areas, such as sickle cell disease that could prove valuable also in the developing world. Expectedly, the pressure will mount from many corners to provide gene therapy at an affordable price. Big pharma players are likely to face this strong head wind, adding further fuel to fire of the moral dilemma of gene therapy pricing, especially for the developing world. As on date, no one knows what percentage of people in the developing world will have access to gene therapy. Even Novartis, reportedly, does not seem to have any plan to make its product available in the developing nations.

Conclusion:

Despite what has happened so far, as described above, looking around, we find a steady flow of gene therapy, some even promise remedial treatment outcomes. Big pharma companies, as well, have commenced a long-haul journey in this direction, with big stake investments.

Regarding, not achieving a huge commercial success with gene therapy, so far, one point is common for all, these are for the treatment of very rare diseases. Probably, because of this reason, some companies, having taken a cue from it, are moving away from ultra-rare diseases. Illustratively, GSK is still looking to use gene therapy in a collaborative platform, to develop treatments for more common diseases, including cancer and beta-thalassemia – another inherited blood disorder – as the above Scientific American article reported.

That said, the point to ponder now, if the effort to come out with a remedial gene therapy for these indications fructifies, would it ensure a long-term commercial viability, alongside giving rise to a moral dilemma on the rationale for gene therapy pricing? This seems to be akin to a ‘chicken and egg’ situation. It will be interesting to witness how it pans out, as we move on.

By: Tapan J. Ray   

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.