[Ip-health] From the media: Making treatment affordable

[Joana Ramos]

The Star Online (Malaysia)
http://thestar.com.my/health/story.asp?file=3D/2005/7/3/health/11352481&sec=
=3Dhealth


Making treatment affordable
BY TEE SHIAO EEK

> GIPAP was initiated to make imatinib available to patients who cannot
> afford it, says Jean-Francois Naa.


THE middle-aged woman stands at the front of the room, clutching a
fistful of notes. Her emotions are palpable as she relates her
experience of having chronic myeloid leukaemia (CML).

Diagnosed in 2001, Mrs Sundram (not her real name) has been through a
difficult time, battling the impact of having the disease and the
side-effects of her first treatment.

GIPAP was initiated to make imatinib available to patients who cannot
afford it, says Jean-Francois Naa.
=93I thought I would not live long. I was quite worried whether I would
have time to spend with my children,=94 she says haltingly.

In 2003, she switched to imatinib, a newer, more effective form of
treatment for CML with fewer side effects. Since then, she has started
feeling a lot more active and is able to spend a lot of time with her
family.

But with imatinib weighing in at an average of RM10,000 per month for
each patient, how can Mrs Sundram, on her husband=92s teaching salary,
afford the treatment?

Fortunately, Mrs Sundram is one of 346 patients in Malaysia on the
Glivec(R) International Patient Assistance Program (GIPAP) initiated by
Novartis Pharmaceuticals.

GIPAP is a patient-based donation programme that provides imatinib to
patients with CML and gastrointestinal stromal tumours (GIST) who are
unable to afford the drug.

=93We (Novartis) knew we had a breakthrough drug for CML and GIST, which
could make major progress in treatment,=94 says Jean-Francois Naa, Head of
Novartis=92 Global Patient Assistance (Asia-Pacific).

However, the question was whether they could make the drug broadly
available to all the patients who needed it.

=93There is always the question of cost,=94 he admits. But the company also
pondered whether it would be ethical to deny the treatment to patients
who would benefit from it.

The CEO of Novartis, Daniel Vasella, then famously made the commitment
that no patient in need of imatinib would be denied it for financial
reasons.

GIPAP was established in 2001 and remains the only patient-based
donation programme by a pharmaceutical company. The programme has just
entered its third year in Malaysia.



Reducing the cost burden

CML is a rare form of leukaemia, estimated to affect only about 500
people in Malaysia. There are even fewer GIST patients, the disease
being so uncommon that medical students are not taught about it in school.

However, doctors treating CML and GIST patients are conscious of the
devastating impact of these diseases.

=93Although the number seems small, the social, emotional and financial
burden on this group of patients is immense,=94 says Dr Chang Kian Meng, a
consultant haematologist in Hospital Kuala Lumpur.

The arrival of imatinib was heralded as a real revolution in treatment
of the disease. Unfortunately, the inevitable question of cost reared
its ugly head.

In the United States, the cost of imatinib for each patient is estimated
at US$30,000 (RM114,000) per year. Novartis recognised the limitations
of such a staggering price tag. So they briefly considered slashing the
cost, so that it would fall below the-then market price of the
alternative treatment, interferon.

However, Novartis claims that there are patients who cannot even afford
to travel to the hospital, much less pay for the drug, though it may be
heavily discounted.

=93Even if you reduce the price to one dollar, you will still have
patients who are not able to afford it,=94 Naa states.

Depending on the dosage, the cost of the treatment in Malaysia can range
from RM8,000 to RM16,000 per month; a price bracket that would be beyond
the reach of the average patient.

=93Fortunately, most patients today get imatinib free of charge under the
auspices of the GIPAP programme,=94 says Dr Chang.

=93So far, we have enrolled more than 10,500 patients (with CML and GIST)
from 74 countries in the programme,=94 says Naa. These make up the
majority of CML and GIST patients in the countries covered by GIPAP,
including poor countries in sub-Saharan Africa, South America and Asia.


Qualifying for GIPAP

Novartis has set out certain specific criteria that patients have to
meet before qualifying for the programme.

First, the patient has to be diagnosed with CML or GIST by a qualified
specialist. The patient also has to be unable to pay for the treatment,
and must not have any form of insurance, reimbursement or other
financial recourse.

=93We won=92t leave the patient without treatment,=94 says Naa, but he insi=
sts
that everyone, including the government and other financial providers,
has to shoulder the responsibility of patient welfare as well.

No one will be left desperate, promises CEO of Novartis Corporation
Malaysia Andrew Moore. =93Patients should use their existing resources
first, then they will automatically fall into qualification criteria=94 if
those resources have been exhausted, he says.

The company has come under fire from certain sectors for one of their
exclusion criteria, which states that the programme is not available in
countries where a generic form of imatinib is available.

A case in point is when India allowed a generic form of imatinib to be
introduced into the market in 2003. Novartis decided to modify their
programme and not accept any new patients, although existing patients on
the programme continued to receive the drug. However, when India granted
exclusive marketing rights to Novartis again, the programme was resumed.

=93We believe that it is not our responsibility anymore, it can also be
the responsibility of the generic company to shoulder the donation
programme,=94 Naa defends his company=92s move.



Fully committed

Novartis has already stated that its commitment is to bear the costs of
providing and distributing the drug worldwide. It will also continue to
supply the drug to every patient on the programme until and unless they
fall out of it, either through failure to follow up or the passing on of
the patient.

=93We need the partnership of everyone: the physicians to register the
patients, and the patients to be compliant,=94 Naa urges.

The programme also depends on the administrative support of The Max
Foundation, an independent organisation that evaluates the patients for
their financial eligibility and maintains the database of patients. The
Foundation also provides support and information to patients,
facilitates access and encourages patients to continue treatment.

Novartis is proud of the started-from-scratch GIPAP because it is unlike
other mass donation programmes.

=93In mass donation, you donate the drugs to an organisation, so you have
no control and you cannot be sure that you will reach the right patients.

=93With a patient-based programme, we have full control of where the drug
is going and we ensure that there is no misuse,=94 Naa explains.

However, the company is reticent about the total monetary value of
imatinib donated since the inception of GIPAP. Naa concedes that it is
=93a lot=94.

Moore firmly insists that =93the objective is not to say =91We=92re giving
away this much=92, but to ensure that people who are unable to have access
to the drug will finally have access to it.=94



--
Joana Ramos, MSW
Cancer Resources & Advocacy
7303 23rd Ave. NE
Seattle, WA  98115
206-229-2420
http://ramoslink.info/