Health technology assessment of hospital drugs: inequality, lack of transparency, and undue waiting

The Swedish Agency for Health and Care Services Analysis (Vårdanalys) is a relatively new government agency, with the mission to strengthen the position of patients and users by analyzing health care and social care services from the perspective of patients and citizens. It has just presented a report that in one swift move has positioned the authority as a key player in the Swedish health care debate.

It is a matter of considerable political discussion whether or not Sweden has too many government authorities. In particular, the multitude of analyzing and evaluating agencies has been the subject of pointed criticism from the opposition. Vårdanalys is one of the latest entrants, and if there is a change in government this coming fall, its future is not at all clear. Be that as it may: the agency has already made its mark, and more is certainly to come if they are allowed to continue.

The report “Värdefullt men inte fullvärdigt – Om nyttan med hälsoekonomiska bedömningar av klinikläkemedel” (Vårdanalys 2014:4) is the result of a government remit to evaluate the project for health technology assessment of medicines used in hospitals. The project in question (“Klinikläkemedelsprojektet ” ) has been active since 2010 with the pricing and reimbursement agency TLV in the lead. It is this project that Vårdanalys has now, in turn, evaluated.

The picture painted in the Vårdanalys report is not a pretty one. Patients who could benefit from a given hospital medicine are left waiting for a protracted period of time. It is not clear when a decision will be taken, there is no information about on which ground the decision will be taken, and to make matters worse the result is likely to be different depending on in which county the patient is resident. Briefly, the result is inequality, lack of transparency, and undue waiting.

Vårdanalys makes a suggestion to cut through the present longwinded, bureaucratic process when it comes to truly life-saving drugs. They should have a “fast lane” to decision. 

Vårdanalys has great respect for the underlying reasons for health technology assessments of all medicines. But they see serious weaknesses in organization and working methods in the project on hospital medicines. Their verdict is that these weaknesses must be addressed when the government decides whether the project on HTA analysis of hospital medicines should be made permanent.

HTA analysis is basically a good thing, but the lack of transparency and legitimacy is serious. And furthermore, this smaller project – in Vårdanalys’ view – has shown problems in how Swedish health care generally manages to handle questions regarding priorities and equality.

Vårdanalys’ report is like a breath of clean air in its clear, dispassionate analysis; albeit slightly depressing. Is it really this bad? On balance: Yes it is.

Lack of transparency is not just a matter for patients to lament. Pharmaceutical companies are like all other companies: clear rules and transparent systems are the basis for sound company decisions. Where there is lack of clarity there is uncertainty, and uncertainty breeds less willingness to invest. This does not bode well for Sweden’s health care system, for its patients – nor for the pharmaceutical industry in Sweden.

Sweden is well on the way to muddle through to a situation where it is no longer a country which embraces innovation. Rather, it is gradually building ever higher obstacles for innovation and new medicines – cloaked in the well-meaning goal of economic control of potentially “galloping cost increases”. This fear, common as it is, does not have much basis in the actual statistics. Sweden’s overall costs for medicines is not “galloping”, quite the contrary. Medicine sales are flat over the last decade, in spite of numerous new medicines being authorized. And new medicines are used to a lesser and lesser extent – a result we see as stemming directly from the ever growing bureaucratic overload for evaluation on many different levels; a process that takes longer and longer to make decisions and which inherently seems to have the basic assumption that older medicines are generally better.

LIF see the developments on the Swedish market for pharmaceuticals as deeply worrying. There are elements of growing problem awareness among stakeholders, primarily on the national level. There is also a very clear political willingness to focus on Life Science innovation on the general level, something which we very much welcome of course. But connecting the dots seems to be very difficult: innovation in pharmaceuticals needs a welcoming environment, a “market” that is willing to use and evaluate the new products, otherwise Life Science R&D will not start to grow again in Sweden. And LIF see Vårdanalys’ report as a serious and well-reasoned analysis, from a reputable government agency, which hopefully will help in turning the trend.

Because it is not just words on a paper, right? We can only hope that it will have real impact; that the powers that be will listen and take action. Because it is about real patients and real needs.

Guest contributor
Anders Blanck, VD/Director General LIF
Läkemedelsindustriföreningen (LIF) is the trade association for the research-based pharmaceutical industry in Sweden with about 80 members and associate companies who represent approximately 80 percent of the total sales of pharmaceuticals in Sweden.