DORVAL, QC, April 1, 2021 /CNW Telbec/ - HLS Therapeutics
Inc. regrets the adoption of a new regulation, published yesterday
in the Gazette officielle du Québec, which limits access to a
support program for new patients suffering from refractory
schizophrenia, and urgently requests a meeting with the
Quebec Minister of Health and
Social Services Christian Dubé.
This regulation will impact access of new patients to the risk
management program called CSAN (CLOZARIL® Support and Assistance
Network), a care portal and patient registry required by Health
Canada for patients prescribed CLOZARIL® (clozapine), a treatment
of last resort prescribed by psychiatrists to treat patients with
refractory schizophrenia who do not respond to other
treatments.
For nearly five years, HLS has enabled new patients to have
access to CSAN and to CLOZARIL by covering the difference in cost
between its medication and the amount reimbursed by RAMQ. By
removing the cost difference, physicians were able to choose the
support system best suited to the needs of their patients, without
any financial impact.
The published regulation was meant to define the exceptions to
the application of Article 80.2 of Law 92, which prohibits the
reimbursement of all, or part of a drug covered by the Quebec general drug insurance plan. However,
although patients currently on treatment will continue to be
able to benefit from access to CSAN/CLOZARIL®, the government
has chosen not to allow for an exception for future patients. Thus,
deprived of financial assistance from CSAN, new patients will not
have access to CSAN unless they pay the difference between the
price of CLOZARIL® and the cost reimbursed by the RAMQ, a near
impossible requirement given the often-precarious circumstances of
this patient population. This regulation will create two classes of
patients, an injustice that could be easily avoided.
"The law stipulates that the Minister of Health can make an
exception on humanitarian grounds which would permit the
continuation of financial support from HLS to all new eligible
patients and thus allow them to choose CSAN, without any financial
impact to the government of Quebec, taxpayers or the Régie d'assurance
maladie du Québec (RAMQ)," said Mr. Gilbert
Godin, CEO of HLS Therapeutics Inc. "It is a question of
compassion and social responsibility. Patients suffering from
refractory schizophrenia are among the most disadvantaged in
Quebec society. Given its stated
commitment to mental health, the government's position doesn't make
sense, especially since no explanation has been provided."
A REAL EXCEPTION
To ensure patient safety, the use of
CLOZARIL ® (clozapine) is well regulated by Health Canada, which
among other things, requires each manufacturer to keep a register
and put in place a monitoring program of hematological parameters.
Such Health Canada directives are important but very uncommon as
only 13 medications in Canada are
required to have this type of risk management program. Of these 13
products, only clozapine will be affected by section 80.2 of Law
92. It is therefore clearly an exceptional situation. Since 2016,
many healthcare professionals, patients and associations have been
asking government for an exception for clozapine. Recently, almost
one hundred of these specialists urgently requested an exception
but to no avail.
"This decision is very regrettable. It will also deprive
French-speaking psychiatrists and nurses' access to Quebec-based expert consultants in their own
language, to the detriment of the health of their new patients,"
said Dr. Jean C Grégoire, cardiologist at the Montreal Heart
Institute and expert consultant to CSAN. "Even though all
manufacturers of clozapine are required to comply with the risk
management rules dictated by Health Canada, there are differences
in the scope and usefulness of the complementary services that
these programs offer. The majority of mental health specialists in
Quebec, whether psychiatrists or
nurse clinicians, consider that CSAN and its unique offering can
have a significant impact on the health and safety of their
patients. For example, the range of services offered by CSAN helps
manage the risks of hematological, cardiovascular, metabolic, and
neurological side effects by providing a 24-hour consultation
service. Paradoxically, it is in new patients that the risk of
relapse, neutropenia and the burden of adherence to mandatory
diagnostic tests are greatest, with 39 blood tests required during
the first year of treatment."
A SOLUTION WITHIN REACH OF THE QUEBEC MINISTER OF HEALTH
We recommend
that the Minister of Health grant an exception to the regulations
for the few drugs subject to a risk management program prescribed
by Health Canada. This real and very limited exception would only
concern clozapine and would not set a precedent that could be used
by other manufacturers. Specifically, the exception would allow new
patients to benefit from HLS's financial assistance program that
pays for the difference between the cost of its product and the
amount paid by RAMQ.
This exception would ensure continued freedom of choice and
access to support services from all manufacturers including CSAN at
no additional cost for RAMQ or patients. In Quebec, clozapine is subject to the Lowest
Price rule. For almost five years now, HLS has paid the difference
between its product and the RAMQ price for new patients thus
ensuring that these new patients have access to its product and
services at no additional cost.
"We would like to discuss our solution directly with Minister
Dubé. Clozapine is the treatment of last resort for these most
precarious, vulnerable and disadvantaged patients, and extreme
precautions are required due to the potential risks and side
effects associated with the use of clozapine. Given the human
tragedy and disproportionate costs to society that are associated
with either avoidance or failure of schizophrenia treatment, there
are many reasons that justify ensuring that this entire patient
population and their caregivers can access the treatment of their
choice," added Mr. Godin.
ABOUT HLS THERAPEUTICS INC.
Formed in 2015, HLS is a
specialty pharmaceutical company focused on the acquisition and
commercialization of late-stage development, commercial stage
promoted and established branded pharmaceutical products in the
North American markets. HLS's focus is on products targeting the
central nervous system and cardiovascular therapeutic areas. HLS's
management team is composed of seasoned pharmaceutical executives
with a strong track record of success in these therapeutic areas
and at managing products in each of these lifecycle stages. For
more information, please visit: www.hlstherapeutics.com
FORWARD LOOKING INFORMATION
This release includes
forward-looking statements regarding HLS and its business. Such
statements are based on the current expectations and views of
future events of HLS's management. In some cases the
forward-looking statements can be identified by words or phrases
such as "may", "will", "expect", "plan", "anticipate", "intend",
"potential", "estimate", "believe" or the negative of these terms,
or other similar expressions intended to identify forward-looking
statements, including, among others, statements with respect to
HLS's pursuit of additional product and pipeline opportunities in
certain therapeutic markets, statements regarding growth
opportunities and expectations regarding financial performance. The
forward-looking events and circumstances discussed in this release
may not occur and could differ materially as a result of known and
unknown risk factors and uncertainties affecting HLS, including
risks relating to the specialty pharmaceutical industry, risks
related to the regulatory approval process, economic factors and
many other factors beyond the control of HLS. Forward-looking
statements and information by their nature are based on assumptions
and involve known and unknown risks, uncertainties and other
factors which may cause HLS's actual results, performance or
achievements, or industry results, to be materially different from
any future results, performance or achievements expressed or
implied by such forward-looking statement or information.
Accordingly, readers should not place undue reliance on any
forward-looking statements or information. A discussion of the
material risks and assumptions associated with this release can be
found in the Company's Annual Information Form dated March 17, 2021 and Management's Discussion and
Analysis dated March 17, 2021, both
of which have been filed on SEDAR and can be accessed at
www.sedar.com. Accordingly, readers should not place undue reliance
on any forward-looking statements or information. Except as
required by applicable securities laws, forward-looking statements
speak only as of the date on which they are made and HLS undertakes
no obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future events,
or otherwise.
SOURCE HLS Therapeutics Inc.