| Effective treatments supported by sound sales and | | | | The last issue, once an initiative has been designed |
| marketing strategies maximize prescription shares for | | | | and the involvement of institutional health actors has |
| pharmaceutical products. But can more be done? | | | | been defined, is how to organize and align resources. |
| The equation "number of units prescribed equals | | | | At a higher level, this implies putting in place |
| number of units sold" holds very rarely for | | | | governance mechanisms; from an operational |
| pharmaceutical products whose consumption does | | | | standpoint, detailing the competences needed and |
| not take place in controlled settings, such as hospitals. | | | | sizing the resources required to run the initiative. As |
| Poor adherence to prescribed treatments may be | | | | the type of competences and the nature of |
| due to a variety of factors, including intolerance to | | | | resources required is somewhat different from the |
| side effects, patient-perceived lack of effectiveness, | | | | core of a pharmaceutical company's operation and will |
| and administration difficulties (e.g. self-injections); this | | | | likely have a temporary nature (due to product life |
| affects, to different degrees, the majority of | | | | cycle and ROI considerations), different make-or-buy |
| diseases whose care takes place at the patient's | | | | solutions must be evaluated to identify the most |
| home. This issue has been increased by the recent | | | | cost-effective solution. |
| trend, common in both Europe and the United States, | | | | How widespread is this model today? Are there any |
| of reducing hospitalization in favor of territorial care, | | | | potential pitfalls that must be taken into consideration |
| in an effort to drive down the average cost per | | | | while considering such an initiative? Do actual results |
| patient, especially for longer-term diseases. | | | | justify this kind of investment? |
| Non-adherence represents one of the most relevant | | | | Adherence-focused initiatives sponsored and |
| health-care challenges today: it can cost billions of | | | | undertaken by pharmaceutical companies are |
| dollars in lost revenues to the global pharmaceutical | | | | somewhat more common in the US, mostly due to |
| industry, and it often increases overall costs for | | | | lower regulatory barriers and the size of the revenue |
| health-care providers or insurers due to the higher | | | | potential to be gained back. Anyway, despite the |
| likelihood of complications and hospitalizations. Studies | | | | difficulty of coping with a highly fragmented legislative |
| on the incidence and impact of this phenomenon are | | | | environment, these kinds of initiatives are gaining a |
| usually pathology-focused; the punctual quantification | | | | foothold and demonstrating their relevance also in |
| of overall costs associated is complex, so that an | | | | Europe, as the multiple sclerosis case suggests. |
| accurate quantification of the overall financial impact | | | | Beyond legislative concerns, there are at least two |
| is not readily available. However, with several medical | | | | important potential pitfalls of the model that can |
| studies confirming non-adherence rates often in the | | | | explain why these initiatives have been lagging behind |
| range of 20 percent to 30% of the prescribed | | | | in EU with respect to the US, and can thus provide |
| population at 12 months for long-term diseases (e.g. | | | | insights for developing and fine-tuning further efforts: |
| Parkinson's and multiple sclerosis), the economic | | | | - The complexity of managing a multitude of |
| relevance becomes manifest. | | | | health-system actors (usually different bodies at local, |
| While adherence has traditionally been perceived as | | | | regional and national level) not always aligned in terms |
| an issue of the health-care delivery system, taking | | | | of priorities and agenda; |
| the initiative to tackle the problem presents a | | | | - The difficulty in quantifying a proven ROI, as these |
| growing opportunity for pharmaceutical companies to | | | | initiatives might be beneficial to the whole market for |
| generate significant economic returns, directly and | | | | a given treatment, without significant impacts on |
| indirectly, especially in those therapy areas where the | | | | market share (thus favoring competitors who did not |
| impact of lost revenues is highest. | | | | invest money in the initiative). |
| These initiatives can lead to improvements in two | | | | There are also important factors that point to an |
| significant areas: | | | | increased relevance of this kind of initiative for the |
| - Boost to sales volumes at no incremental sales | | | | sales and marketing strategies of pharmaceutical |
| efforts, maximizing the value extracted from the | | | | companies: |
| existing prescription base; | | | | - Significant changes, both from new legislation issued |
| - Improved relationships with the economic and | | | | in several key markets and from the ethical codes of |
| administrative actors influencing the sales process of | | | | pharmaceutical companies, on the scope of marketing |
| pharmaceutical products (e.g. regional agencies), | | | | instruments, and hence necessity to find new |
| supporting them in reaching their own health-care | | | | destinations for part of the marketing budgets; |
| targets. | | | | - A track of previous experiences in the design and |
| How can a pharmaceutical company design, develop | | | | management of adherence-focused efforts, whose |
| and implement such an initiative? There are two main | | | | best practices can provide significant support in |
| steps to be followed: a. deeply understanding | | | | overcoming the two pitfalls mentioned above. |
| patients, the "consumers"; and b. defining how to | | | | The most relevant consideration remains the |
| approach the health system. This requires trying to | | | | bottom-line impact. Data on actual non-adherence |
| get a deeper involvement (when improving the | | | | enable a back-of-the-envelope calculation of how |
| relationship with economic buyers is a primary goal of | | | | large the potential revenues (and profits) to be |
| the initiative) with an "institutional marketing" | | | | recouped are, while results from similar initiatives (the |
| approach, or aligning key actors and getting the | | | | multiple sclerosis case discusses good examples) |
| regulatory clearings eventually required. | | | | provide a sense of how such efforts can turn into a |
| Gaining an in-depth understanding of the end-users of | | | | money-making tool, enabling the company to fully |
| medical treatments provides excellent insights about | | | | capitalize on its sales and marketing budgets. |
| the root causes of non-adherence behaviors and | | | | Case 1 - Partnering with regions to reduce overall |
| how these could be acted upon to eliminate, or at | | | | cost of Gastro-esophageal Reflux Disease care |
| least reduce, consumption barriers; this usually can be | | | | Gastro-esophageal Reflux Disease (GERD) occurs |
| achieved through a four-step process: | | | | when the lower esophageal sphincter (the valve |
| - Get to know and segment non-customers: What is | | | | separating the esophagus and stomach) does not |
| the actual non-adherence incidence? What are the | | | | close properly, allowing acid to back up into the |
| characteristics of the patients in which it is | | | | esophagus; it is a chronic condition and may lead to |
| concentrated (previous treatment history, stage of | | | | more serious medical implications. |
| the disease, access to insurance, socio-demographic | | | | Several drugs are available for treatment, even |
| factors)? What are the characteristics of patients | | | | though they usually account for roughly 40 percent |
| with the highest risk of turning into "non-customers"? | | | | to 50% of the overall health-service cost of care; |
| Are there patient clusters characterized by irregular | | | | costs (both medication and others) rise quickly for |
| consumption, while others who discontinue | | | | patients migrating from a mild to a severe stage of |
| altogether? This preliminary activity can rely on a mix | | | | the disease, a risk increased by the frequent |
| of retrospective-studies analysis and ad hoc activities; | | | | non-adherence to both prescribed treatment and |
| it provides a comprehensive perspective on "non | | | | prescribed modifications to the individual's lifestyle. |
| customers," including their characteristics, larger and | | | | A leading global pharmaceutical company had to |
| smaller clusters, and a preliminary set of | | | | contend with reference prices for GERD treatments |
| non-adherence predictors. | | | | in some regions of a large European market, leading |
| - Identify adherence barriers along the whole patient | | | | to a potential loss of up to 60% of turnover and a |
| flow: What are the main factors turning patients into | | | | risk of adoption of this scheme in all other regions. |
| "non-customers"? What are the most critical steps | | | | The company approached the issue in regions still |
| experienced by patients while moving across the | | | | without a reference-price system by partnering with |
| different steps of their care path? At what stage do | | | | them to support achieving budgetary goals by |
| they discontinue treatment - if they ever started it? | | | | shifting the focus from the overall cost of treatment |
| A detailed mapping and analysis of all the occurrences | | | | to enhanced prevention and, especially, improved |
| experiences by a patient and of all the interactions | | | | compliance for mild patients. In the partnership, the |
| with the different actors (GPs, hospitals, specialists, | | | | company supported regions both in the design of |
| health system / insurance, relatives, other care | | | | levers (screening and prevention packages; case |
| givers) from the time of initial presentation to the | | | | management system to enable follow-up, monitoring |
| physician until the end of the care path highlights key | | | | and outreach on mild patients) and in their |
| consumption barriers and the underlying rationales. | | | | implementation in pilot roll-outs. This value proposition |
| - Map actionable levers: What are the main service | | | | of "helping the health system to create additional |
| components that could help overcome the barriers | | | | funds (or saving resources) whatever the product |
| mapped along the patient flow? Is there anything the | | | | choice" proved credible and effective, also avoiding |
| pharmaceutical company may do to lessen | | | | stringent clinical trials or requirements of ethics |
| consumption barriers experienced by patients, | | | | committees. |
| eventually focusing on specific target clusters? What | | | | The pilot tests provided satisfactory results. For the |
| are the priority actions and the expected results? | | | | NHS, total pathology cost-oriented measures proved |
| What are the interactions needed with institutional | | | | to be more beneficial than pure medications |
| health providers, and how can they be managed? | | | | price-cutting, and also offered administrators a |
| Are there opportunities to build or improve the | | | | politically desirable outcome: savings through better |
| relationship with economic and administrative buyers? | | | | health-care management. For the company, it avoided |
| - Design intervention packages: Are there viable and | | | | the expansion of price-reduction risk, while creating |
| cost-effective actions the pharmaceutical company | | | | incremental revenues through more systematic |
| may put in place to support treatment adherence - | | | | screening and enhanced compliance. |
| maximizing the value generated from actual | | | | Case 2 - Designing and implementing direct |
| prescriptions? What are the markets in which this | | | | patient-support systems to boost multiple sclerosis |
| solution is to be implemented? Are there specific legal | | | | treatment adherence |
| issues or delivery requirements to be dealt with at | | | | Multiple sclerosis (MS) is an autoimmune condition |
| the national level? Is it appropriate to envisage a "hot | | | | affecting the capability of nerve cells in the brain and |
| housing" approach before planning a widespread | | | | spinal cord to communicate with each other; its |
| launch? Who are the key individuals (medical, | | | | course is characterized by relapses (acute attacks) |
| administrative) for whom an early involvement is to | | | | leading to disability increases and intervals of disease |
| be planned? | | | | stability. While no final cure is known, there are some |
| Identifying and detailing a potential intervention | | | | drugs in the market (disease modifying therapies - |
| strategy is not enough; its implementation must take | | | | DMT) enabling to slow disease progression, mostly by |
| place in someone else's domain: that of the | | | | preventing new relapses and the ensuing disabilities. |
| institutional health-care providers. Two different | | | | With an aggregate worldwide value of several billion |
| approaches and strategies may be envisaged, | | | | dollars, the market for multiple sclerosis is dominated |
| depending on the goals and priorities of the | | | | by four companies; R&D pipelines suggest |
| pharmaceutical company. | | | | further entrants in this highly profitable market. |
| At a minimum level, it can opt for a "low | | | | Treatment of multiple sclerosis is hampered by |
| involvement" approach: communicate the initiative at | | | | significant non-adherence issues. Long diagnosis time |
| the appropriate institutional level (national, regional), | | | | and poor communication at diagnosis, administration |
| get all the required regulatory approvals, and keep an | | | | through self-injection, adverse effects, lack of a |
| update communication channel on the results of the | | | | structured medical and social follow-up, and |
| initiative. Alternatively, the launch of an | | | | patient-perceived treatment ineffectiveness are just |
| adherence-focused initiative may involve a co-delivery | | | | some of the causes leading approximately 25%-30% |
| with health-system actors, whereby the "front-end" | | | | of patients -- as confirmed by several medical studies |
| provider is usually the health system, while the | | | | -- to discontinue the prescribed treatment within 12 |
| pharmaceutical company adds specific resources or | | | | months. Additionally, efforts by the health system to |
| components to reinforce some aspects of care | | | | tackle non-adherence issues are usually very poor, as |
| provision. There are various factors that affect the | | | | no infrastructures and services allow a punctual |
| results of these two models (they can have a range | | | | post-prescription follow-up; at most, some limited |
| of different outcomes between the two extremes): | | | | services are provided at the local level by patient |
| - Pharmaceutical company goals: whether the primary | | | | associations. |
| objective is a sales growth by increasing treatment | | | | This "vacuum" of presidium of the post-prescription |
| adherence, or strengthening the relationships with | | | | phase provided pharmaceutical companies an |
| key influences in administrative positions; | | | | opportunity to step in, designing and delivering |
| - Initiative interdependence with institutional | | | | additional services to support patients in keeping |
| health-care delivery: the more the initiative foreseen | | | | compliant to the prescription made. A detailed |
| is interconnected to the existing care pathway (e.g. | | | | mapping of the patient flow (from prescription to end |
| case management, such as in the first case | | | | of treatment) enables the identification of "critical |
| discussed), the higher the need of co-delivery with | | | | points", which can be ranked in terms of the impact |
| the health system, while a more stand-alone | | | | or feasibility of solution (costs, ease of |
| approach can be undertaken in the case of an | | | | implementation) and around which the company can |
| initiative that complements the health-care offering, | | | | build different service components (such as |
| for instance with a post-prescription follow-up (e.g. | | | | self-injection guides or the provision of in-house |
| the second case presented, on multiple sclerosis); | | | | nurses) and their delivery systems (directly, especially |
| - Product life cycle stage: a higher degree of | | | | where no legal constraints are in place, or through |
| involvement might be envisaged, for instance, for a | | | | patient associations or the national health service). |
| new treatment that is to undergo its market launch, | | | | Detailed studies in settings where pharmaceutical |
| often within a broader effort aimed at determining | | | | companies provided patient-assistance services |
| reimbursement status or formulate position; | | | | demonstrate a significant impact (and ROI), even in |
| - Legislation: while some national legislation (in | | | | the short term, in terms of patient compliance; |
| particular in the US) make fairly simple a direct | | | | indirect benefits are achievable in terms of increased |
| contact between a pharmaceutical company and a | | | | prescriptions due to a higher confidence in physicians. |
| patient, others (such as, in different degrees, the | | | | Additionally, this approach provides a potentially |
| European ones) impose more barriers, favoring (if not | | | | valuable defense for the incumbent product against |
| almost requiring) a co-delivery solution (where entities | | | | potential new entrants with a more favorable |
| such as patient associations might be a substitute for | | | | adherence profile (e.g. tablets versus self-injection), |
| health-system bodies). | | | | reducing the threat of market share dilution. |